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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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ASCENT LE - 18257200064595

3.5MM X 42MM C-C BIASED ANGLE SCREW ASSY
Orthofix US LLC
66-3742
In Commercial Distribution

  • 18257200064595 ()


  • Bone-screw internal spinal fixation system, non-sterile

Real Intelligence - 00885556775400

JOURNEY II XR POLY TRIAL INSERT RIGHT (CC)
Smith & Nephew, Inc.
ROB10080
In Commercial Distribution

  • 00885556775400 ()
ROB10080

  • Instrument tray, reusable

Real Intelligence - 00885556775394

JOURNEY II XR POLY TRIAL INSERT LEFT (CC)
Smith & Nephew, Inc.
ROB10079
In Commercial Distribution

  • 00885556775394 ()
ROB10079

  • Instrument tray, reusable

PROGENIX® PUTTY and PROGENIX® PLUS - 00613994236425

DBM 005005 PROGENIX DBM 5 CC SRVC FEE
MEDTRONIC SOFAMOR DANEK, INC.
005005
Not in Commercial Distribution

  • 00613994236425 ()

  • 5 cc volume


  • Bone matrix implant, human-derived

NanoFuse Bioactive Matrix - 1.0 cc - 00858686006034

Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser
AMEND SURGICAL, INC.
NAN109-01
In Commercial Distribution

  • 00858686006034 ()

  • Total Volume: 1.0 Milliliter
NAN109-01

  • Cadaveric-donor/synthetic mineral bone graft

5-Pack, 100 cc Syringe, Luer-locking - 00851607003518

Syringe, Luer-Locking, 100cc, 5-Pack
MEDSPIRA, LLC
RMD-010-016
In Commercial Distribution

  • 10851607003515 ()
  • 00851607003518 ()


  • Manometric gastrointestinal motility analysis system

Actifix CC Conical Narrow Platform - D169BSCC3516

No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 16mm
In Commercial Distribution

  • D169BSCC3516 ()
BIOS3516CC

  • Dental implant system

Actifix CC Conical Narrow Platform - D169BSCC3513

No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 13mm
In Commercial Distribution

  • D169BSCC3513 ()
BIOS3513CC

  • Dental implant system

Actifix CC Conical Narrow Platform - D169BSCC3511

No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 11.5mm
In Commercial Distribution

  • D169BSCC3511 ()
BIOS3511CC

  • Dental implant system

Actifix CC Conical Narrow Platform - D169BSCC3510

No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 10mm
In Commercial Distribution

  • D169BSCC3510 ()
BIOS3510CC

  • Dental implant system
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