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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Integra® Bovine Pericardium Dural Graft is a natural, resorbable, collagenous device for use in the repair of dura mater. The device is derived from bovine pericardium and is manufactured using a multistep proprietary process which gently cleans and dehydrates the tissue. The device is terminally sterilized by gamma irradiation. The device must be sutured in place.
Integra Lifesciences Corporation
BP10207
Not in Commercial Distribution

  • M268BP102070 ()
  • 10381780074212 ()

  • Width: 7 Centimeter
  • Length: 2 Centimeter
BP10207

  • Dura mater graft, bovine
DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGenXS Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGenXS Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Integra Lifesciences Corporation
DXM1057
In Commercial Distribution

  • 10381780070993 ()
  • M269DXM10571 ()

  • 5 in x 7 in 12.5 cm x 17.5 cm
DXM1057

  • Dura mater graft, bovine
DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGenXS Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGenXS Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Integra Lifesciences Corporation
DXM1033
In Commercial Distribution

  • 10381780070979 ()
  • M269DXM10331 ()

  • 3 in x 3 in 7.5 cm x 7.5 cm
DXM1033

  • Dura mater graft, bovine
DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGenXS Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGenXS Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Integra Lifesciences Corporation
DXM1013
In Commercial Distribution

  • 10381780070955 ()
  • M269DXM10131 ()

  • 1 in x 3 in 2.5 cm x 7.5 cm
DXM1013

  • Dura mater graft, bovine
DuraGen® Plus Dural Regeneration Matrix, 3 in x 3 in (7.5 cm x 7.5 cm)
Integra Lifesciences Corporation
DP5033
In Commercial Distribution

  • 30381780070942 ()
  • 10381780070948 ()
  • M269DP50331 ()

  • 3 in x 3 in 7.5 cm x 7.5 cm
DP-5033

  • Dura mater graft, bovine
DuraGen® Plus Dural Regeneration Matrix, 2 in x 2 in (5 cm x 5 cm)
Integra Lifesciences Corporation
DP5022
In Commercial Distribution

  • 30381780070935 ()
  • 10381780070931 ()
  • M269DP50221 ()

  • 2 in x 2 in 5 cm x 5 cm
DP-5022

  • Dura mater graft, bovine
DuraGen® Plus Dural Regeneration Matrix, 1 in x 3 in (2.5 cm x 7.5 cm)
Integra Lifesciences Corporation
DP5013
In Commercial Distribution

  • 30381780070928 ()
  • 10381780070924 ()
  • M269DP50131 ()

  • 1 in x 3 in 2.5 cm x 7.5 cm
DP-5013

  • Dura mater graft, bovine
DuraGen® Plus Dural Regeneration Matrix, 1 in x 1 in (2.5 cm x 2.5 cm)
Integra Lifesciences Corporation
DP5011
In Commercial Distribution

  • 30381780070911 ()
  • 10381780070917 ()
  • M269DP50111 ()

  • 1 in x 1 in 2.5 cm x 2.5 cm
DP-5011

  • Dura mater graft, bovine
Collagen Dural Regeneration Matrix
COLLAGEN MATRIX, INC.
DMOC45
In Commercial Distribution

  • 00813954026114 ()

  • 4in x 5in (10cm x 12.5cm)
DMOC45

  • Dura mater graft, bovine
Collagen Dural Regeneration Matrix
COLLAGEN MATRIX, INC.
DMOC33
In Commercial Distribution

  • 00813954026107 ()

  • 3in x 3in (7.5cm x 7.5cm)
DMOC33

  • Dura mater graft, bovine
Collagen Dural Regeneration Matrix
COLLAGEN MATRIX, INC.
DMOC22
In Commercial Distribution

  • 00813954026091 ()

  • 2in x 2in (5cm x 5cm)
DMOC22

  • Dura mater graft, bovine
Collagen Dural Regeneration Matrix
COLLAGEN MATRIX, INC.
DMOC13
In Commercial Distribution

  • 00813954026084 ()

  • 1in x 3in (2.5cm x 7.5cm)
DMOC13

  • Dura mater graft, bovine
No Description
COLLAGEN MATRIX, INC.
DMOC11
In Commercial Distribution

  • 00813954026077 ()

  • 1in x 1in (2.5cm x 2.5cm)
DMOC11

  • Dura mater graft, bovine
Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS45
In Commercial Distribution

  • 00813954025902 ()

  • 4in x 5in (10 cm x 12.5cm)
DFCS45

  • Dura mater graft, bovine
Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS33
In Commercial Distribution

  • 00813954025896 ()

  • 3in x 3in (7.5cm x 7.5cm)
DFCS33

  • Dura mater graft, bovine
Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS22
In Commercial Distribution

  • 00813954025889 ()

  • 2in x 2in (5cm x 5cm)
DFCS22

  • Dura mater graft, bovine
Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS13
In Commercial Distribution

  • 00813954025872 ()

  • 1in x 3in (2.5cm x 7.5cm)
DFCS13

  • Dura mater graft, bovine
Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS11
In Commercial Distribution

  • 00813954025865 ()

  • 1in x 1in (2.5cm x 2.5cm)
DFCS11

  • Dura mater graft, bovine
DuraGen® Dural Graft Matrix 4 in x 5 in (10cm x12.5cm)
Integra Lifesciences Corporation
ID4501
In Commercial Distribution

  • 10381780023616 ()
  • M269ID45011 ()

  • 4 in x 5 in 10 cm x 12.5 cm
ID4501

  • Dura mater graft, bovine
DuraGen® Plus Dural Regeneration Matrix, 5 in x 7 in (12.5 cm x 17.5 cm)
Integra Lifesciences Corporation
DP1057
In Commercial Distribution

  • 10381780023487 ()
  • M269DP10571 ()

  • 5 in x 7 in 12.5 cm x 17.5 cm
DP-1057

  • Dura mater graft, bovine
DuraGen® Plus Dural Regeneration Matrix , 4 in x 5 in
Integra Lifesciences Corporation
DP1045
In Commercial Distribution

  • 10381780023470 ()
  • M269DP10451 ()

  • 4 in x 5 in 10 cm x 12.5 cm
DP-1045

  • Dura mater graft, bovine
Integra® DuraFlex™ Suturable Dural Graft 12 cm x 16 cm
Integra Lifesciences Corporation
BP11216
In Commercial Distribution


  • Length: 12 Centimeter
  • Width: 16 Centimeter
BP11216

  • Dura mater graft, bovine
Integra® DuraFlex™ Suturable Dural Graft 8 cm x 12 cm
Integra Lifesciences Corporation
BP10812
In Commercial Distribution


  • Width: 12 Centimeter
  • Length: 8 Centimeter
BP10812

  • Dura mater graft, bovine
Integra® DuraFlex™ Suturable Dural Graft 6 cm x 8 cm
Integra Lifesciences Corporation
BP10608
In Commercial Distribution


  • Width: 8 Centimeter
  • Length: 6 Centimeter
BP10608

  • Dura mater graft, bovine
Integra® DuraFlex™ Suturable Dural Graft 4 cm x 5 cm
Integra Lifesciences Corporation
BP10405
In Commercial Distribution


  • Width: 5 Centimeter
  • Length: 4 Centimeter
BP10405

  • Dura mater graft, bovine
Integra® DuraFlex™ Suturable Dural Graft 2 cm x 7 cm
Integra Lifesciences Corporation
BP10207
In Commercial Distribution


  • Length: 2 Centimeter
  • Width: 7 Centimeter
BP10207

  • Dura mater graft, bovine
Durepair™ 7.5cm x 7.5cm (3" x 3")
TEI BIOSCIENCES INC.
62105
In Commercial Distribution


  • Width: 3 Inch
  • Length: 7.5 Centimeter
  • Length: 3 Inch
  • Width: 7.5 Centimeter
62105

  • Dura mater graft, bovine
Durepair™ 2.5cm x 2.5cm (1" x 1")
TEI BIOSCIENCES INC.
62111
In Commercial Distribution


  • Length: 1 Inch
  • Width: 2.5 Centimeter
  • Length: 2.5 Centimeter
  • Width: 1 Inch
62111

  • Dura mater graft, bovine
Durepair™ 5.0cm x 5.0cm (2" x 2")
TEI BIOSCIENCES INC.
62100
In Commercial Distribution


  • Length: 5 Centimeter
  • Length: 2 Inch
  • Width: 2 Inch
  • Width: 5 Centimeter
62100

  • Dura mater graft, bovine
Durepair™ 10.0cm x 12.5cm (4" x 5")
TEI BIOSCIENCES INC.
62110
In Commercial Distribution


  • Width: 5 Inch
  • Length: 4 Inch
  • Length: 10 Centimeter
  • Width: 12.5 Centimeter
62110

  • Dura mater graft, bovine
Durepair™ 12.5cm x 20.0cm (5" x 8")
TEI BIOSCIENCES INC.
62158
In Commercial Distribution


  • Length: 12.5 Centimeter
  • Width: 20 Centimeter
  • Length: 5 Inch
  • Width: 8 Inch
62158

  • Dura mater graft, bovine
Durepair™ 2.5cm x 7.5cm (1" x 3")
TEI BIOSCIENCES INC.
62106
In Commercial Distribution


  • Length: 7.5 Centimeter
  • Width: 2.5 Centimeter
  • Length: 3 Inch
  • Width: 1 Inch
62106

  • Dura mater graft, bovine
DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE
MEDTRONIC PS MEDICAL, INC.
62158
Not in Commercial Distribution

  • 00643169063907 ()

  • Width: 12.5 Centimeter
  • Length: 20.3 Centimeter


  • Dura mater graft, bovine
No Description
MANI, INC.
9
In Commercial Distribution

  • 04546951500399 ()
  • 14546951500396 ()
9

  • Polyester suture, non-bioabsorbable, multifilament
Tinted Glow Powder
JBC and Company
9
In Commercial Distribution

  • D85109 ()
9

  • Dental appliance fabrication material, resin
TIDI Positioning Aid Kits Kit, Various Sizes 12 per Set
TIDI PRODUCTS, LLC
9
Not in Commercial Distribution

  • 00618125168231 ()


  • Multifunction body cushion
No Description
Bio-Research Associates, Inc.
9
In Commercial Distribution

  • 00860003499948 ()


  • Jaw physiology evaluation system
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
9
In Commercial Distribution

  • 00860461001783 ()
FG0064

  • Dental milling system, CAD/CAM, laboratory
Powdered Sterile Latex Surgical Gloves
Beijing Reagent Latex Products Factory
9
In Commercial Distribution

  • 16936610210304 ()
  • 06936610210307 ()
  • 26936610210301 ()


  • Hevea-latex surgical glove, powdered
Powder free Sterile Latex Surgical Gloves
Beijing Reagent Latex Products Factory
9
In Commercial Distribution

  • 16936610210212 ()
  • 06936610210215 ()
  • 26936610210219 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
eRAD PACS v9
Erad, Inc.
9
In Commercial Distribution

  • 00866994000255 ()


  • Radiological PACS software
No Description
Ad-Tech Medical Instrument Corporation
9
In Commercial Distribution

  • 00841823109705 ()
BF08R-SP61X-0C3

  • Depth electrode
The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal. The containers are designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture. In summary, all PureWay® Sharps Collector containers are blow molded using High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure. 2 gallon twin pack sharps disposal ship back system (Includes two 2 gallon sharps container, box, bag, zip tie).
PUREWAY COMPLIANCE
9
In Commercial Distribution

  • 10853022008069 ()
  • 00853022008062 ()

  • Total Volume: 2.0 Gallon
40022

  • Sharps container
SE CUTTING INSTRUMENT #9
NORDENT MANUFACTURING INC
9
In Commercial Distribution

  • 00840018633728 ()


  • Margin finishing dental file/rasp, reusable
ProOcular Daily Disposable Contact Lens Power -9
CARLSBAD TECHNOLOGY INC.
-9
Not in Commercial Distribution

  • 40816816880631 ()
  • 30816816880634 ()
  • 10816816880630 ()
  • 00816816880633 ()


  • Soft corrective contact lens, daily-disposable
Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation
Dental CADCAM Software
Dental Wings Inc
9
In Commercial Distribution

  • D840DWOSCAD1 ()


  • Dental milling system, CAD/CAM, laboratory
9" Alligator Rongeur
MEDISURGE LLC
9"
In Commercial Distribution

  • G611BIO110430 ()
BIO-1-1043

  • Orthopaedic joint/limb rongeur
9" Alligator Rongeur
SIGNAL MEDICAL CORPORATION
9"
In Commercial Distribution

  • B046BIO110430 ()
BIO-1-1043

  • Orthopaedic joint/limb rongeur
PACS Device
Les Systèmes Médicaux Intelerad Incorporée
9
In Commercial Distribution

  • B228INTELEHEART0 ()


  • Radiological PACS software
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