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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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The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement.
CONEXTIONS MEDICAL INC
FA0001
In Commercial Distribution

  • 10861445000300 ()
  • 00861445000303 ()
FA0001

  • Tendon coaptation implant deployment tool
  • Tendon coaptation implant
One pouched device, 1F002
Safepath Medical, Inc.
1F002
In Commercial Distribution

  • 00861298002622 ()


  • Silk suture
Euwe Membrane Placement Instrument
HU-FRIEDY MFG. CO., LLC
PMPIE
In Commercial Distribution

  • 10889950019716 ()
PMPIE

  • Dental implant system
Membrane Placement Instrument
HU-FRIEDY MFG. CO., LLC
PMPI6
In Commercial Distribution

  • 10889950019709 ()
PMPI6

  • Dental implant system
Membrane Placement Instrument
HU-FRIEDY MFG. CO., LLC
PMPI
In Commercial Distribution

  • 10889950019693 ()
PMPI

  • Dental implant system
Modified PMPI Membrane Placement Inst.
HU-FRIEDY MFG. CO., LLC
PMP7002
In Commercial Distribution

  • 10889950019686 ()
PMP7002

  • Dental implant system
MXC-3 and Bio-reign Granules, F/G, Sterile
RANFAC CORP.
ACG-10
In Commercial Distribution

  • 10857878007306 ()
  • 00857878007309 ()

  • Needle Gauge: 11 Gauge
  • Length: 11 Centimeter
  • Needle Gauge: 8 Gauge
  • Length: 15 Centimeter
ACG-10

  • Bone access cannula
  • Synthetic bone graft
No Description
SYNCARDIA SYSTEMS, LLC
297052-001
In Commercial Distribution

  • 00858000003305 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
395103-001
In Commercial Distribution

  • 00858000003299 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
295600-001
In Commercial Distribution

  • 00858000003282 ()


  • Ventricular prosthesis system, pneumatically-powered
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