Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5810 BLADE
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7023-5810
In Commercial Distribution

  • 00858736006144 ()
  • 00858736006175 ()
7023-5810

  • Haemostatic knife
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5815 BLADE
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7013-5815
In Commercial Distribution

  • 00858736006120 ()
  • 00858736006205 ()
7013-5815

  • Haemostatic knife
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5815 BLADE
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7023-5815
In Commercial Distribution

  • 00858736006113 ()
  • 00858736006205 ()
7023-5815

  • Haemostatic knife
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7023-9050
In Commercial Distribution

  • 00858736006106 ()
  • 00858736006236 ()
7023-9050

  • Haemostatic knife
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5712 BLADE - QTY 10
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7023-5712
In Commercial Distribution

  • 00858736006076 ()
  • 00858736006182 ()
7023-5712

  • Haemostatic knife
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5715 BLADE - QTY 24
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7013-5715
In Commercial Distribution

  • 00858736006045 ()
  • 00858736006137 ()
7013-5715

  • Haemostatic knife
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 8050 HANDLE - QTY 1
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7013-8050
In Commercial Distribution

  • 00858736006021 ()
7013-8050

  • Haemostatic knife
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 FOOTSWITCH
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7013-8410
In Commercial Distribution

  • 00858736006007 ()
7013-8410

  • Haemostatic knife
The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
4.0
In Commercial Distribution

  • 00858733006154 ()
MI-IRS-MDSB-22

  • Surgical retractor/retraction system blade, reusable
The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
1.0
In Commercial Distribution

  • 00858733006130 ()
MI-IRS-T-22

  • Device sterilization/disinfection container, reusable
The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
3.0
In Commercial Distribution

  • 00858733006116 ()
MI-IRS-XLB-P01

  • Surgical retractor/retraction system blade, reusable
The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
3.0
In Commercial Distribution

  • 00858733006109 ()
MI-IRS-LB-P01

  • Surgical retractor/retraction system blade, reusable
The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
3.0
In Commercial Distribution

  • 00858733006086 ()
MI-IRS-SB-P01

  • Surgical retractor/retraction system blade, reusable
The TIE device is a tourniquet-style surgical instrument used to control the target location of knot seating during precise suture knot tying and delivery applications. The COLLAR device is a flexible surgical retractor designed to retract valve leaflet tissue when inserted within the valve annulus. The device consists of a main body component which extends laterally to become the retraction wings. The distal tips of the retraction wings are bifurcated for additional tissue traction. The posterior aspect of the device has a stiffening rib along the superior border and a stabilization flange along the inferior border. The COLLAR device is available in 2 sizes (small and large) which are packaged together in a disposable set with the TIE device.
Biorep Technologies, Inc.
7.0
In Commercial Distribution

  • 10858733006038 ()
  • 00858733006031 ()
MI-COTIE-001

  • Suturing unit, single-use
  • Hand-held surgical retractor, single-use
14FR COUDE URINEMETER TRAY
MEDLINE INDUSTRIES, INC.
URO170814C
In Commercial Distribution

  • 40889942905790 ()
  • 10889942905799 ()

  • Catheter Gauge: 14 French
URO170814C

  • Indwelling urethral catheterization kit, adult
"Elastic Stain Kit and its components are used as a special stain kit to identify elastic fibers. The elastic fibers stain black due to the dye lake created by the hematoxylin, ferric chloride and iodine mixture. The fibers are overstained and then differentiated with ferric chloride to break the dye-lake complex. To ensure fibers are not over-differentiated, slides should be examined during this step under the microscope. Elastic fibers will be stained black and sharply defined. The Van Gieson solution then counterstains the tissue with collagen staining red and other tissue structures, yellow. The Van Gieson solution will also remove some of the elastic fiber staining so the knowledge of a professional is required for adequate use. After staining, care should be taken in choosing a compatible mounting medium as some mountants can leach the picric acid from the Van Gieson counterstain."
RICHARD-ALLAN SCIENTIFIC COMPANY
Van Gieson Stain Solution
In Commercial Distribution

  • 00673693089463 ()
880011

  • Biological stain IVD
"Elastic Stain Kit and its components are used as a special stain kit to identify elastic fibers. The elastic fibers stain black due to the dye lake created by the hematoxylin, ferric chloride and iodine mixture. The fibers are overstained and then differentiated with ferric chloride to break the dye-lake complex. To ensure fibers are not over-differentiated, slides should be examined during this step under the microscope. Elastic fibers will be stained black and sharply defined. The Van Gieson solution then counterstains the tissue with collagen staining red and other tissue structures, yellow. The Van Gieson solution will also remove some of the elastic fiber staining so the knowledge of a professional is required for adequate use. After staining, care should be taken in choosing a compatible mounting medium as some mountants can leach the picric acid from the Van Gieson counterstain."
RICHARD-ALLAN SCIENTIFIC COMPANY
Weigert’s Iodine Solution
In Commercial Distribution

  • 00673693089425 ()
88009

  • Biological stain IVD
"Elastic Stain Kit and its components are used as a special stain kit to identify elastic fibers. The elastic fibers stain black due to the dye lake created by the hematoxylin, ferric chloride and iodine mixture. The fibers are overstained and then differentiated with ferric chloride to break the dye-lake complex. To ensure fibers are not over-differentiated, slides should be examined during this step under the microscope. Elastic fibers will be stained black and sharply defined. The Van Gieson solution then counterstains the tissue with collagen staining red and other tissue structures, yellow. The Van Gieson solution will also remove some of the elastic fiber staining so the knowledge of a professional is required for adequate use. After staining, care should be taken in choosing a compatible mounting medium as some mountants can leach the picric acid from the Van Gieson counterstain."
RICHARD-ALLAN SCIENTIFIC COMPANY
Ferric Chloride Solution
In Commercial Distribution

  • 00673693089401 ()
88008

  • Biological stain IVD
"Elastic Stain Kit and its components are used as a special stain kit to identify elastic fibers. The elastic fibers stain black due to the dye lake created by the hematoxylin, ferric chloride and iodine mixture. The fibers are overstained and then differentiated with ferric chloride to break the dye-lake complex. To ensure fibers are not over-differentiated, slides should be examined during this step under the microscope. Elastic fibers will be stained black and sharply defined. The Van Gieson solution then counterstains the tissue with collagen staining red and other tissue structures, yellow. The Van Gieson solution will also remove some of the elastic fiber staining so the knowledge of a professional is required for adequate use. After staining, care should be taken in choosing a compatible mounting medium as some mountants can leach the picric acid from the Van Gieson counterstain."
RICHARD-ALLAN SCIENTIFIC COMPANY
Alcoholic Hematoxylin Solution
In Commercial Distribution

  • 00673693089388 ()
88007

  • Biological stain IVD
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
Edge-Rite™ Low Profile Disposable Microtome Blades
In Commercial Distribution

  • 00673693074384 ()
4280L

  • Microtome blade IVD, single-use
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
Edge-Rite™ High Profile Disposable Microtome Blades
In Commercial Distribution

  • 00673693074322 ()
4275H

  • Microtome blade IVD, single-use
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
Adamas Blades for Disposable Magnetic Blade Carriers 80 mm 10/cs
In Commercial Distribution

  • 00673693064231 ()
160040

  • Microtome blade IVD, reusable
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
Adamas Blades for Disposable Magnetic Blade Carriers 60 mm 10/cs
In Commercial Distribution

  • 00673693064200 ()
160010

  • Microtome blade IVD, reusable
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
Tungsten Carbide Knife, 16 CM
In Commercial Distribution

  • 00673693063814 ()
152120

  • Microtome blade IVD, reusable
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
Microtome Knife, 30 CM, D
In Commercial Distribution

  • 00673693063807 ()
152100

  • Microtome blade IVD, reusable
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
Microtome Knife, 25 CM, D
In Commercial Distribution

  • 00673693063791 ()
152090

  • Microtome blade IVD, reusable
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
Microtome Knife, 22 CM, D
In Commercial Distribution

  • 00673693063784 ()
152080

  • Microtome blade IVD, reusable
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
Microtome Knife, 16 CM, D
In Commercial Distribution

  • 00673693063777 ()
152070

  • Microtome blade IVD, reusable
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
Microtome Knife, 12 CM, D
In Commercial Distribution

  • 00673693063760 ()
152060

  • Microtome blade IVD, reusable
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
Microtome Knife, 30CM, C
In Commercial Distribution

  • 00673693063753 ()
152050

  • Microtome blade IVD, reusable
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
Microtome Knife, 16 CM, C
In Commercial Distribution

  • 00673693063500 ()
152020

  • Microtome blade IVD, reusable
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
Microtome Knife, 12 CM, C
In Commercial Distribution

  • 00673693063494 ()
2222004

  • Microtome blade IVD, reusable
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
RICHARD-ALLAN SCIENTIFIC COMPANY
MX35 Ultra Microtome Blade
In Commercial Distribution

  • 00673693458856 ()
3053835

  • Microtome blade IVD, single-use
The Brux-TMD Quicksplint is a patented anterior bite plate that covers the upper or lower front teeth from bicuspid through bicuspid. It is a two component device with a hard plastic shell and a softer compliant lining that conforms to the supporting teeth. The operator may optionally place it on the anterior maxillary or mandibular arch. While it is worn, the Brux-TMD Quicksplint temporarily inhibits the full force of parafunctional teeth clenching, and gives the pericranial musculature and opportunity to relax. This reduces the muscular tension that underlies the pain associated with many bruxism headaches and the pain associated with TMD dysfunction. It reduces the muscle tension in trigeminal innervated cranial-facial muscles, thereby reducing the pain occurrence. In addition, it physically protects the teeth from nighttime bruxing activities by covering the dental occlusal surfaces with a durable plastic covering.
TRUER MEDICAL, INC.
90525
In Commercial Distribution

  • 00859290006205 ()
  • 00859290006199 ()
  • 00859290006182 ()
90600FG

  • Mouthguard, reusable
Standard shaver blade, disposable
RELIGN CORPORATION
R-10026
In Commercial Distribution

  • 10859273007264 ()
  • 00859273007267 ()

  • Outer Diameter: 4.2 Millimeter
R-10026

  • Arthroscopic shaver system blade, single-use
Standard shaver blade, disposable
RELIGN CORPORATION
R-10024
In Commercial Distribution

  • 10859273007240 ()
  • 00859273007243 ()

  • Outer Diameter: 3.4 Millimeter
R-10024

  • Arthroscopic shaver system blade, single-use
Shaver Handpiece, Autoclavable
RELIGN CORPORATION
R-10023
In Commercial Distribution

  • 00859273007236 ()
R-10023

  • Arthroscopic shaver system handpiece, electrically-powered
Multi-functional shaver blade, disposable
RELIGN CORPORATION
R-10014
In Commercial Distribution

  • 10859273007141 ()
  • 00859273007144 ()

  • Outer Diameter: 5.0 Millimeter
R-10014

  • Orthopaedic bur, single-use
  • Endoscopic electrosurgical electrode, bipolar, single-use
  • Arthroscopic shaver system blade, single-use
Standard shaver blade, disposable
RELIGN CORPORATION
R-10012
In Commercial Distribution

  • 10859273007127 ()
  • 00859273007120 ()

  • Outer Diameter: 3.4 Millimeter
R-10012

  • Arthroscopic shaver system blade, single-use
Shaver Handpiece, Autoclavable
RELIGN CORPORATION
R-10011
Not in Commercial Distribution

  • 00859273007113 ()
R-10011

  • Arthroscopic shaver system handpiece, electrically-powered
Multi-functional shaver blade, disposable
RELIGN CORPORATION
R-10008
In Commercial Distribution

  • 10859273007080 ()
  • 00859273007083 ()

  • Outer Diameter: 4.2 Millimeter
R-10008

  • Orthopaedic bur, single-use
  • Endoscopic electrosurgical electrode, bipolar, single-use
  • Arthroscopic shaver system blade, single-use
Shaver Handpiece
RELIGN CORPORATION
R-10002
Not in Commercial Distribution

  • 00859273007021 ()
R-10002

  • Arthroscopic shaver system handpiece, electrically-powered
System Controller with Footswitch
RELIGN CORPORATION
R-10001
In Commercial Distribution

  • 00859273007014 ()
R-10001

  • Arthroscopic shaver/electrosurgical system generator
IVC-THREE Blastocyst Medium is a synthetic, defined culture medium composed of a balanced mixture of salts, amino acid, vitamins and other nutrients designed to support embryo growth and blastocyst development in vitro. IVC-THREE Blastocyst Medium has been formulated without phosphate, which may be detrimental to blastocyst development (Quinn P, Moinipanah R, Steinberg J, Weathersbee P: Fertil Steril 1995;63:922-924). IVC-THREE Blastocyst Medium may be used as a stand alone medium or as the second stage of a sequential medium protocol.
INVITROCARE, INCORPORATED
2007-V
In Commercial Distribution

  • 00859268006107 ()
2007-V

  • IVF medium
IVC-TWO is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures.The formulation of IVC-TWO is substantially equivalent to the glucose and phosphate free HTF formulation published by Quinn et al (Quinn P, Moinipanah R, Steinberg J, Weathersbee P: Fertil Steril 1995;63:922-924). IVC-TWO is designed to support early stages of embryonic growth (up to four days post-fertilization). IVC-TWO has been formulated without phosphate, which may be detrimental to embryo blastocyst development. IVC-TWO may be used as a stand alone medium or as the first stage of a sequential medium protocol.
INVITROCARE, INCORPORATED
2008-V
In Commercial Distribution

  • 00859268006091 ()
2008-V

  • IVF medium
PONTiS Achilles Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3 MFSS suture with 2 curved needles (white wrap) 1x size #3 MFSS suture with 2 curved needles (black wrap) 1x SS Crimp Collar for #3 SS sutures Supplied pouched, sterilized with EO.
PONTIS ORTHOPAEDICS, LLC
600-4001
In Commercial Distribution

  • 00859210006070 ()

  • Size #3 Suture
600-4001

  • Metallic suture, multifilament
PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains: 1x Pre-drill, size 0.063" diameter x 4" length 1x Pre-drill, size 0.078" diameter x 4" length 1x Pre-drill, size 0.094" diameter x 4" length > For replacement of components of the PONTiS Crimp Instrument Sets (p/n 400-5563 or 400-5565) Supplied Non-Sterile.
PONTIS ORTHOPAEDICS, LLC
400-3015
In Commercial Distribution

  • 00859210006049 ()

  • Length: 4 Inch
  • Outer Diameter: 0.094 Inch
  • Outer Diameter: 0.078 Inch
  • Outer Diameter: 0.063 Inch
400-3015

  • Orthopaedic trocar blade, reusable
PONTiS Flexor Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3-0 MFSS suture with 2 curved needles (white wrap) 1x size #3-0 MFSS suture with 2 curved needles (black wrap) 1x SS Crimp Collar Supplied pouched, sterilized with EO.
PONTIS ORTHOPAEDICS, LLC
400-3011
In Commercial Distribution

  • 00859210006001 ()

  • 3-0 suture size
400-3011

  • Metallic suture, multifilament
No Description
SCANMED, LLC
516PH3001
In Commercial Distribution

  • 00859193006463 ()


  • MRI system coil, radio-frequency
No Description
SCANMED, LLC
516SI3001
In Commercial Distribution

  • 00859193006180 ()


  • MRI system coil, radio-frequency
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