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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 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 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 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
eRAD PACS v9
Erad, Inc.
9
In Commercial Distribution

  • 00866994000255 ()


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

  • 00841823109705 ()
BF08R-SP61X-0C3

  • Depth electrode
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