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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Ø4/ L=15
Megagen Implant Co. Ltd
ST4015
In Commercial Distribution

  • 08806388236831 ()
ST4015C

  • Screw endosteal dental implant, two-piece
Ø4/ L=13
Megagen Implant Co. Ltd
ST4013
In Commercial Distribution

  • 08806388236824 ()
ST4013C

  • Screw endosteal dental implant, two-piece
Ø4/ L=11.5
Megagen Implant Co. Ltd
ST4011
In Commercial Distribution

  • 08806388236817 ()
ST4011C

  • Screw endosteal dental implant, two-piece
Ø4/ L=10
Megagen Implant Co. Ltd
ST4010
In Commercial Distribution

  • 08806388236800 ()
ST4010C

  • Screw endosteal dental implant, two-piece
Ø4/ L=8.5
Megagen Implant Co. Ltd
ST4008
In Commercial Distribution

  • 08806388236794 ()
ST4008C

  • Screw endosteal dental implant, two-piece
Ø4/ L=7
Megagen Implant Co. Ltd
ST4007
In Commercial Distribution

  • 08806388236787 ()
ST4007C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=15
Megagen Implant Co. Ltd
ST3515
In Commercial Distribution

  • 08806388236770 ()
ST3515C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=13
Megagen Implant Co. Ltd
ST3513
In Commercial Distribution

  • 08806388236763 ()
ST3513C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=11.5
Megagen Implant Co. Ltd
ST3511
In Commercial Distribution

  • 08806388236756 ()
ST3511C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=10
Megagen Implant Co. Ltd
ST3510
In Commercial Distribution

  • 08806388236749 ()
ST3510C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=8.5
Megagen Implant Co. Ltd
ST3508
In Commercial Distribution

  • 08806388236732 ()
ST3508C

  • Screw endosteal dental implant, two-piece
The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
763.08PA
In Commercial Distribution

  • B15176308PA0 ()
763.08PA

  • Cranial orthosis
The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
763.08A
In Commercial Distribution

  • B15176308A0 ()
763.08A

  • Cranial orthosis
The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
709.08PA
In Commercial Distribution

  • B15170908PA0 ()
709.08PA

  • Cranial orthosis
The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
709.08A
In Commercial Distribution

  • B15170908A0 ()
709.08A

  • Cranial orthosis
The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
704.08PA
In Commercial Distribution

  • B15170408PA0 ()
704.08PA

  • Cranial orthosis
Linear ST, 70cm 8 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-70
In Commercial Distribution

  • M365SC2218700 ()

  • 70 cm Length
SC-2218-70

  • Analgesic spinal cord electrical stimulation system
Linear ST, 50cm 8 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-50
In Commercial Distribution

  • M365SC2218500 ()

  • 50 cm Length
SC-2218-50

  • Analgesic spinal cord electrical stimulation system
Linear ST, 30cm 8 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-30
In Commercial Distribution

  • M365SC2218300 ()

  • 30 cm Length
SC-2218-30

  • Analgesic spinal cord electrical stimulation system
Nitrile Powder Free Textured Black Exam Gloves, Non- Sterile, Chemo Tested, size XL
Uniseal
775-9
In Commercial Distribution

  • 30744514077592 ()
  • 20744514077595 ()
  • 10744514077598 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Powder Free Textured Black Exam Gloves, Non- Sterile, Chemo Tested, size L
Uniseal
775-8
In Commercial Distribution

  • 30744514077585 ()
  • 20744514077588 ()
  • 10744514077581 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Powder Free Textured Black Exam Gloves, Non- Sterile, Chemo Tested, size M
Uniseal
775-7
In Commercial Distribution

  • 30744514077578 ()
  • 20744514077571 ()
  • 10744514077574 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Powder Free Textured Black Exam Gloves, Non- Sterile, Chemo Tested, size S
Uniseal
775-6
In Commercial Distribution

  • 30744514077561 ()
  • 20744514077564 ()
  • 10744514077567 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Powder Free Textured Black Exam Gloves, Non- Sterile, Chemo Tested, size XXL
Uniseal
775-0
In Commercial Distribution

  • 30744514077509 ()
  • 20744514077502 ()
  • 10744514077505 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Symmetry® Blade; Universal Ring Retractor; 2 1/3 in x 7 in; w/Lip
SYMMETRY SURGICAL INC.
58-0086
In Commercial Distribution

  • 00887482101513 ()

  • Width: 2.33333 Inch
  • Depth: 7 Inch
58-0086

  • Surgical retractor/retraction system blade, reusable
Symmetry® Forceps, St. Clair, Adenoid, 5 mm x 10 mm Ring Jaw, 7 5/8 in
SYMMETRY SURGICAL INC.
71-5018
In Commercial Distribution

  • 00887482122495 ()

  • Width: 5 Millimeter
  • Depth: 10 Millimeter
  • Length: 7.625 Inch
71-5018

  • Dressing/utility forceps, scissors-like, reusable
No Description
FGX INTERNATIONAL INC.
10240675.JCP
In Commercial Distribution

  • 00887661511980 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10240676.JCP
In Commercial Distribution

  • 00887661511942 ()


  • Tinted non-prescription spectacles
Symmetry® Retractor, St. Marks Deep Pelvic, w/Lip, 15° Angle, 11 in Working Length
SYMMETRY SURGICAL INC.
50-9028S
In Commercial Distribution

  • 00887482074800 ()

  • Angle: 15 degree
  • Length: 11 Inch
50-9028S

  • Hand-held surgical retractor, reusable
Symmetry® Retractor, St Marks Deep Pelvic, 15° Angle, w/Lip, 9 in Working Length, 13 2/5 in, 34 cm
SYMMETRY SURGICAL INC.
50-9027S
In Commercial Distribution

  • 00887482074794 ()

  • Angle: 15 degree
  • Length: 13.4 Inch
50-9027S

  • Hand-held surgical retractor, reusable
Symmetry® Retractor, St. Marks Deep Pelvic, w/o Lip
SYMMETRY SURGICAL INC.
50-9026S
In Commercial Distribution

  • 00887482074787 ()
50-9026S

  • Hand-held surgical retractor, reusable
Symmetry® Retractor, St. Marks Deep Pelvic, w/Lip, 15° Angle, 7 in Blade Length, 13 in, 330 mm
SYMMETRY SURGICAL INC.
50-9025S
In Commercial Distribution

  • 00887482074770 ()

  • Angle: 15 degree
  • Length: 13 Inch
50-9025S

  • Hand-held surgical retractor, reusable
Symmetry® Retractor, St. Marks, w/Lip, 5 in Working Length, 11 1/2 in
SYMMETRY SURGICAL INC.
50-9024S
In Commercial Distribution

  • 00887482074763 ()

  • Length: 11.5 Inch
50-9024S

  • Hand-held surgical retractor, reusable
Symmetry® Retractor, St. Marks Deep Pelvic, w/Lip
SYMMETRY SURGICAL INC.
50-9023S
In Commercial Distribution

  • 00887482074749 ()
50-9023S

  • Hand-held surgical retractor, reusable
Symmetry® Retractor, St. Marks Deep Pelvic, w/Lip
SYMMETRY SURGICAL INC.
50-9020S
In Commercial Distribution

  • 00887482074725 ()
50-9020S

  • Hand-held surgical retractor, reusable
Symmetry® Retractor, St. Marks, w/Lip, 2-2 1/2 in Taper, 7 in
SYMMETRY SURGICAL INC.
502-002
In Commercial Distribution

  • 00887482074466 ()

  • Length: 7 Inch
502-002

  • Hand-held surgical retractor, reusable
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190016715 ()
901141nt

  • Bone file/rasp, manual, reusable
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190016708 ()
901131nt

  • Bone file/rasp, manual, reusable
LW SET,SNP,DIN,TEL,64CM/ 25.2IN,AAMI,5LW/ST,1/ST
SPACELABS HEALTHCARE (WASHINGTON), INC
ECG Cables & Leadwires
In Commercial Distribution

  • 10841522102134 ()

  • 64 cm/25.2in Length
012-0605-10

  • Electrocardiographic lead set, reusable
LDWR SET,SNAP,EEG,4CH,61CM/24IN,IEC,11LW/ST,1/ST
SPACELABS HEALTHCARE (WASHINGTON), INC
90481
In Commercial Distribution

  • 10841522101861 ()
012-0444-01

  • Electrocardiographic lead set, reusable
LDWR SET,SNAP,EEG,2CH,61CM/24IN,IEC,5LW/ST,1/ST
SPACELABS HEALTHCARE (WASHINGTON), INC
90481
In Commercial Distribution

  • 10841522101854 ()
012-0444-00

  • Electrocardiographic lead set, reusable
LDWR SET,SNAP,DIN,ECG,61CM/24IN,AAMI,5LW/ST,1/ST
SPACELABS HEALTHCARE (WASHINGTON), INC
ECG Cables & Leadwires
Not in Commercial Distribution

  • 10841522100734 ()

  • 61 cm /24" Length
012-0285-11

  • Electrocardiographic lead set, reusable
LDWR SET,PINCH,DIN,61CM/ 24 IN,AAMI,3LW/ST, 1/ST
SPACELABS HEALTHCARE (WASHINGTON), INC
ECG Cables & Leadwires
In Commercial Distribution

  • 10841522100680 ()

  • 61 cm/ 24" Length
012-0284-11

  • Electrocardiographic lead set, reusable
LDWR SET,SNAP,DIN,ECG,61CM/24IN,AAMI,3LW/ST,1/ST
SPACELABS HEALTHCARE (WASHINGTON), INC
ECG Cables & Leadwires
In Commercial Distribution

  • 10841522100642 ()

  • 61 cm/24" length
  • 61 m/24 inch Length
012-0283-11

  • Electrocardiographic lead set, reusable
Personal Use Kit OC-Auto, for SSM Health St. Mary's St. Louis Hospital
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-SSMMO
In Commercial Distribution

  • 00816917025469 ()


  • Faecal occult blood IVD, reagent
No Description
Biomet Orthopedics, LLC
35-351564
In Commercial Distribution

  • 00880304359642 ()

  • .062 (D) X 9 (L) SNG/ST
35-351564

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
35-351534
In Commercial Distribution

  • 00880304359581 ()

  • .045 (D) X 9 (L) SNG/ST
35-351534

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
35-351208
In Commercial Distribution

  • 00880304359390 ()

  • .062 (D) X 4 (L) SNG/ST
35-351208

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
35-351558
In Commercial Distribution

  • 00887868101458 ()

  • .054 (D) X 4 (L) SNG/ST
35-351558

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
35-351540
In Commercial Distribution

  • 00887868101434 ()

  • .045 (D) X 4 (L) SNG/ST
35-351540

  • Orthopaedic bone wire
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