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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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DURA-GUARD Dural Repair Patch - 00085412531007

DURA-GUARD Dural Repair Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. DURA-GUARD Dural Repair Patch is chemically sterilized using ethanol and propylene oxide. DURA-GUARD Dural Repair Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. DURA-GUARD Dural Repair Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
DG0608SN
In Commercial Distribution

  • 00085412531007 ()
DG0608SN

  • Dura mater graft, bovine

DURA-GUARD Dural Repair Patch - 00085412530987

DURA-GUARD Dural Repair Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. DURA-GUARD Dural Repair Patch is chemically sterilized using ethanol and propylene oxide. DURA-GUARD Dural Repair Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25°C. DURA-GUARD Dural Repair Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
DG0404SN
In Commercial Distribution

  • 00085412530987 ()
DG0404SN

  • Dura mater graft, bovine

DURA-GUARD Dural Repair Patch - 00085412530956

DURA-GUARD Dural Repair Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. DURA-GUARD Dural Repair Patch is chemically sterilized using ethanol and propylene oxide. DURA-GUARD Dural Repair Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. DURA-GUARD Dural Repair Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
DG0209SN
In Commercial Distribution

  • 00085412530956 ()
DG0209SN

  • Dura mater graft, bovine

DURA-GUARD Dural Repair Patch - 00085412531045

DURA-GUARD Dural Repair Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. DURA-GUARD Dural Repair Patch is chemically sterilized using ethanol and propylene oxide. DURA-GUARD Dural Repair Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. DURA-GUARD Dural Repair Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
DG1016SN
In Commercial Distribution

  • 00085412531045 ()
DG1016SN

  • 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

GS - 00847865010665

GS HIV Combo Ag/Ab EIA, 960 Tests
Bio-RAD Laboratories, Inc.
26218
Not in Commercial Distribution

  • 00847865010665 ()

  • 960 tests
26218

  • HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)

GS - 00847865010658

GS HIV Combo Ag/Ab EIA, 192 Tests
Bio-RAD Laboratories, Inc.
26217
Not in Commercial Distribution

  • 00847865010658 ()

  • 192 Tests
26217

  • HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)

BioPAK - 00860003499948

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

  • 00860003499948 ()


  • Jaw physiology evaluation system

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

TIDI - 00618125168231

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

  • 00618125168231 ()


  • Multifunction body cushion

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

Macro Depth Electrode - 00841823109705

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

  • 00841823109705 ()
BF08R-SP61X-0C3

  • Depth electrode

Alligator Rongeur - B046BIO110430

9" Alligator Rongeur
SIGNAL MEDICAL CORPORATION
9"
In Commercial Distribution

  • B046BIO110430 ()
BIO-1-1043

  • Orthopaedic joint/limb rongeur

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

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

InteleHeart - B228INTELEHEART0

PACS Device
Les Systèmes Médicaux Intelerad Incorporée
9
In Commercial Distribution

  • B228INTELEHEART0 ()


  • Radiological PACS software

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

NORDENT MANUFACTURING INC - 00840018633728

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

  • 00840018633728 ()


  • Margin finishing dental file/rasp, reusable

DWOS - D840DWOSCAD1

Dental CADCAM Software
Dental Wings Inc
9
In Commercial Distribution

  • D840DWOSCAD1 ()


  • Dental milling system, CAD/CAM, laboratory

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

GLASS VAN - 18904233119838

GLASS VAN STAINLESS STEEL STERILE SURGICAL BLADE #9 INDIVIDUALLY PACKED MYCO REORDER # 2003-09
NIRAJ INDUSTRIES PRIVATE LIMITED
#9
In Commercial Distribution

  • 28904233119835 ()
  • 18904233119838 ()
  • 58904233119836 ()
  • 08904233119831 ()
01983

  • Manual scalpel blade, single-use

NA - 00810050243933

KIT, RECTANGLE. Includes: 126-00-001 - RECTANGLE, 6" x 4" x .50" (00810050243834), 126-00-002 - RECTANGLE, 6" x 4" x 1 " (00810050243841), 126-00-003 - RECTANGLE, 6" x 4" x 1.50" (00810050243858), 126-00-004 - RECTANGLE, 6" x 4" x 2" (00810050243865)
DOMICO MED-DEVICE, LLC
9
In Commercial Distribution

  • 00810050243933 ()


  • Multifunction body cushion
  • Radiological general body-part positioner

RayStation - 07350002010174

No Description
Raysearch Laboratories AB (Publ)
9
In Commercial Distribution

  • 07350002010174 ()


  • Radiation therapy software

Chemoment - 06976009589997

No Description
Chemoment Materials Co., Ltd.
9
In Commercial Distribution

  • 06976009589997 ()


  • Silicone dental impression material

Ever One - 06946430401267

Berman airway is used to establish the airway and prevent the tongue fall and the airway block.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
9#
In Commercial Distribution

  • 26946430401261 ()
  • 16946430401264 ()
  • 06946430401267 ()


  • Oropharyngeal airway, single-use

EVER READY FIRST AID - 06946430401083

Berman airway is used to establish the airway and prevent the tongue fall and the airway block.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
9#
In Commercial Distribution

  • 26946430401087 ()
  • 16946430401080 ()
  • 06946430401083 ()


  • Oropharyngeal airway, single-use

DEXIS™ Software - EKAV101034120

Enterprise
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034120 ()
PLU238

  • Radiology information system application software
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