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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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Procellera Single Layer OTC, 4"x 4"
Vomaris Wound Care, Inc.
4" x 4"
In Commercial Distribution

  • 00810198030389 ()
VSC-0404

  • Bioelectric wound dressing
Procellera Single Layer OTC, 2"x2"
Vomaris Wound Care, Inc.
2"x 2"
In Commercial Distribution

  • 00810198030372 ()
VSC-0202

  • Bioelectric wound dressing
Procellera Single Layer Rx 8" x 8"
Vomaris Wound Care, Inc.
8" X 8"
In Commercial Distribution

  • 00810198030327 ()
  • 00810198030303 ()
  • 00810198030334 ()
  • 00810198030341 ()
VSR-0808

  • Bioelectric wound dressing
Procellera Power Pack, 4"x4" Composite, & Energel
Vomaris Wound Care, Inc.
4"x4" CD & Energel
In Commercial Distribution

  • 00810198030266 ()
VHK-0404-05

  • Bioelectric wound dressing
JumpStart Pin Site Kit
ARTHREX, INC.
ABS-4059
In Commercial Distribution

  • 10888867351247 ()
  • 00888867351240 ()
ABS-4059

  • Bioelectric wound dressing
CUSA® Clarity Sterilization Tray
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7136
In Commercial Distribution

  • 10381780126270 ()
C7136

  • Device sterilization/disinfection container, reusable
Implant Caddy II, Fixcet
Xtant Medical Holdings, Inc.
X063-1003
In Commercial Distribution

  • M697X06310030 ()
  • M697X06310031 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case II, Fixcet
Xtant Medical Holdings, Inc.
X063-1002
In Commercial Distribution

  • M697X06310020 ()
  • M697X06310021 ()


  • Device sterilization/disinfection container, reusable
PrimaLOK FF 45mm Implant Assembly, 2 Pack, Sterile
OSTEOMED LLC
800-1145-SP-02
Not in Commercial Distribution

  • 00845694031929 ()

  • Length: 45 Millimeter
800-1145-SP-02

  • Orthopaedic bone screw, non-bioabsorbable, sterile
PrimaLOK FF 40mm Implant Assembly, 2 Pack, Sterile
OSTEOMED LLC
800-1140-SP-02
Not in Commercial Distribution

  • 00845694031912 ()

  • Length: 40 Millimeter
800-1140-SP-02

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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