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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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STEINER BIOTECHNOLOGY LLC.
SteinerBio Socket Graft 0.5 cc
In Commercial Distribution

  • 00860010170106 ()


  • Synthetic bone graft
CMFlex Block for bone graft 38 x 38 x 9 (mm)
Dimension INX Corp
CMFB13
In Commercial Distribution

  • 00860009902008 ()
  • 10860009902005 ()
  • 30860009902009 ()
  • 20860009902002 ()

  • Length: 38 Millimeter
  • Width: 38 Millimeter
  • Height: 9 Millimeter


  • Synthetic bone graft
TendoNova Disposable Unit 60mm Kit-Single
Tendonova Corporation
DU1F60L-K
In Commercial Distribution

  • 00860009899865 ()

  • Length: 60 Millimeter


  • Skin topical coupling gel
  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use
  • Orthopaedic implant aiming arm
TendoNova Disposable Unit 80mm Kit-Single
Tendonova Corporation
DU1F80L-K
In Commercial Distribution

  • 00860009899858 ()

  • Length: 80 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Spiral blade
  • Skin topical coupling gel
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use
TendoNova Disposable Unit 60mm Kit
Tendonova Corporation
DU5F60L-K
In Commercial Distribution

  • 00860009899841 ()

  • Length: 60 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Skin topical coupling gel
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use
Integrity Orthopaedics Anchor Array
Integrity Orthopaedics, Inc
901002
In Commercial Distribution

  • 00860009782235 ()
901002

  • Tendon/ligament bone anchor, non-bioabsorbable
Integrity Orthopaedics Delivery Instrument, included with Anchor Array System Kit
Integrity Orthopaedics, Inc
902001
In Commercial Distribution

  • 00860009782211 ()
902001

  • Orthopaedic inorganic implant inserter/extractor, single-use
Integrity Orthopaedics Anchor Array, included with Anchor Array System Kit.
Integrity Orthopaedics, Inc
901001
In Commercial Distribution

  • 00860009782204 ()
901001

  • Tendon/ligament bone anchor, non-bioabsorbable
Marrow Access Device in Product Box
Marrow Access Technologies
MAT-102-4000
In Commercial Distribution

  • 00860009769212 ()


  • Subchondral bone needling device
Marrow Access Device in Product Box
Marrow Access Technologies
MAT-101-4000
In Commercial Distribution

  • 00860009769205 ()


  • Subchondral bone needling device
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