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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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DuraGen XS™ Dural Regeneration Matrix - 10381780070962

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
DXM1022
In Commercial Distribution

  • 10381780070962 ()
  • M269DXM10221 ()

  • 2 in x 2 in 5 cm x 5 cm
DXM1022

  • Dura mater graft, bovine

DuraGen® Plus - 10381780070948

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 - 10381780070931

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

DuraMatrix-Onlay Conform - 00813954026114

Collagen Dural Regeneration Matrix
COLLAGEN MATRIX, INC.
DMOC45
In Commercial Distribution

  • 00813954026114 ()

  • 4in x 5in (10cm x 12.5cm)
DMOC45

  • Dura mater graft, bovine

DuraMatrix-Onlay Conform - 00813954026107

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

DuraMatrix-Onlay Conform - 00813954026091

Collagen Dural Regeneration Matrix
COLLAGEN MATRIX, INC.
DMOC22
In Commercial Distribution

  • 00813954026091 ()

  • 2in x 2in (5cm x 5cm)
DMOC22

  • Dura mater graft, bovine

DuraMatrix-Onlay Conform - 00813954026084

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

DuraMatrix-Onlay Conform - 00813954026077

No Description
COLLAGEN MATRIX, INC.
DMOC11
In Commercial Distribution

  • 00813954026077 ()

  • 1in x 1in (2.5cm x 2.5cm)
DMOC11

  • Dura mater graft, bovine

DurAdapt - 00813954025902

Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS45
In Commercial Distribution

  • 00813954025902 ()

  • 4in x 5in (10 cm x 12.5cm)
DFCS45

  • Dura mater graft, bovine

DurAdapt - 00813954025896

Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS33
In Commercial Distribution

  • 00813954025896 ()

  • 3in x 3in (7.5cm x 7.5cm)
DFCS33

  • Dura mater graft, bovine

DurAdapt - 00813954025889

Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS22
In Commercial Distribution

  • 00813954025889 ()

  • 2in x 2in (5cm x 5cm)
DFCS22

  • Dura mater graft, bovine

DurAdapt - 00813954025872

Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS13
In Commercial Distribution

  • 00813954025872 ()

  • 1in x 3in (2.5cm x 7.5cm)
DFCS13

  • Dura mater graft, bovine

DurAdapt - 00813954025865

Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS11
In Commercial Distribution

  • 00813954025865 ()

  • 1in x 1in (2.5cm x 2.5cm)
DFCS11

  • Dura mater graft, bovine

Integra® Bovine Pericardium Dural Graft - 10381780074243

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
BP10812
Not in Commercial Distribution

  • M268BP108120 ()
  • 10381780074243 ()

  • Length: 8 Centimeter
  • Width: 12 Centimeter
BP10812

  • Dura mater graft, bovine

Integra® Bovine Pericardium Dural Graft - 10381780074229

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
BP10405
Not in Commercial Distribution

  • M268BP104050 ()
  • 10381780074229 ()

  • Length: 4 Centimeter
  • Width: 5 Centimeter
BP10405

  • Dura mater graft, bovine

DuraGen XS™ Dural Regeneration Matrix - 10381780070993

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

DuraGen XS™ Dural Regeneration Matrix - 10381780070979

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

DuraGen XS™ Dural Regeneration Matrix - 10381780070955

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 - 10381780070924

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 - 10381780070917

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

DuraGen Plus™ Spinal Matrix - 10381780070726

DuraGen Plus Dural Regeneration Matrix- Spinal Matrix is an absorbable implant for repair of dural defects. DuraGen Plus Dural Regeneration Matrix-Spinal Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen Plus Dural Regeneration Matrix-Spinal Matrix is two 1 inch x 3 inch (2.5cm x 7.5xm) dural regeneration matrices supplied sterile, non-pyrogenic, for single use in double peel packages.
Integra Lifesciences Corporation
51100213
Not in Commercial Distribution

  • 10381780070726 ()
  • 00381780070729 ()
  • M269511002131 ()

  • 1 inch x 3 inch (2.5cm x 7.5cm)
51100213

  • Dura mater graft, bovine

Integra® DuraFlex® - 10381780511373

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® - 10381780511366

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® - 10381780511359

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® - 10381780511342

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® - 10381780511335

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™ - 10381780540892

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™ - 10381780540878

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™ - 10381780540854

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™ - 10381780540823

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™ - 10381780540786

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™ - 10381780540762

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

Durepair® - 00643169063907

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

MANI Sutures Polyester - 04546951500399

No Description
MANI, INC.
9
In Commercial Distribution

  • 04546951500399 ()
  • 14546951500396 ()
9

  • Polyester suture, non-bioabsorbable, multifilament

Luminary Blue Polymer - D85109

Tinted Glow Powder
JBC and Company
9
In Commercial Distribution

  • D85109 ()
9

  • Dental appliance fabrication material, resin

Snow Lotus - 06936610210307

Powdered Sterile Latex Surgical Gloves
Beijing Reagent Latex Products Factory
9
In Commercial Distribution

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


  • Hevea-latex surgical glove, powdered

Snow Lotus - 06936610210215

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 - 00866994000255

eRAD PACS v9
Erad, Inc.
9
In Commercial Distribution

  • 00866994000255 ()


  • Radiological PACS software

uLab Systems uDesign - 00860461001783

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

BioPAK - 00860003499948

No Description
Bio-Research Associates, Inc.
9
In Commercial Distribution

  • 00860003499948 ()


  • Jaw physiology evaluation system

ProOcular Daily Disposable Contact Lens - 10816816880630

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

PureWay® - 10853022008069

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

Alliant Biotech - G611BIO110430

9" Alligator Rongeur
MEDISURGE LLC
9"
In Commercial Distribution

  • G611BIO110430 ()
BIO-1-1043

  • Orthopaedic joint/limb rongeur

coDiagnostiX - D835CDX1

Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

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


  • Diagnostic x-ray digital imaging system workstation

DWOS - D840DWOSCAD1

Dental CADCAM Software
Dental Wings Inc
9
In Commercial Distribution

  • D840DWOSCAD1 ()


  • Dental milling system, CAD/CAM, laboratory

Macro Depth Electrode - 00841823109705

No Description
Ad-Tech Medical Instrument Corporation
9
In Commercial Distribution

  • 00841823109705 ()
BF08R-SP61X-0C3

  • Depth electrode

TIDI - 00618125168231

TIDI Positioning Aid Kits Kit, Various Sizes 12 per Set
TIDI PRODUCTS, LLC
9
Not in Commercial Distribution

  • 00618125168231 ()


  • Multifunction body cushion

NORDENT MANUFACTURING INC - 00840018633728

SE CUTTING INSTRUMENT #9
NORDENT MANUFACTURING INC
9
In Commercial Distribution

  • 00840018633728 ()


  • Margin finishing dental file/rasp, reusable

WebPAX® - B127WP90

WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations.
HEART IMAGING TECHNOLOGIES, LLC
9
In Commercial Distribution

  • B127WP90 ()
n/a

  • Medical image management system

InteleHeart - B228INTELEHEART0

PACS Device
Les Systèmes Médicaux Intelerad Incorporée
9
In Commercial Distribution

  • B228INTELEHEART0 ()


  • Radiological PACS software
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