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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
FA0002
In Commercial Distribution

  • 10861445000317 ()
  • 00861445000310 ()
FA0002

  • Tendon coaptation implant deployment tool
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
IV SET, DEHP FREE, 60 DROPS/ML, 84" LENGTH, CONICAL SPIKE WITH AIR VENT, CHECK VALVE, TWO INJECTION SITES, ROLLER CLAMP, ROTATING LUER LOCK CONNECTOR.
GHC HEALTHCARE, INC.
81-007A
In Commercial Distribution

  • 40872237008719 ()
  • 00872237008711 ()


  • Basic intravenous administration set, noninvasive
IV SET, DEHP FREE, 10 DROPS/ML, 100" LENGTH, CONICAL SPIKE WITH AIR VENT, FLOW CONTROLLER, TWO NEEDLE-FREE Y-PORTS, SLIDE CLAMP, ROTATING LUER LOCK CONNECTOR.
GHC HEALTHCARE, INC.
81-005A
In Commercial Distribution

  • 40872237008696 ()
  • 00872237008698 ()


  • Basic intravenous administration set, noninvasive
IV SET, DEHP FREE, 20 DROPS/ML, 84" LENGTH, CONICAL SPIKE WITH AIR VENT, CHECK VALVE, TWO INJECTION SITES, ROLLER CLAMP, ROTATING LUER LOCK CONNECTOR.
GHC HEALTHCARE, INC.
81-004A
In Commercial Distribution

  • 40872237008689 ()
  • 00872237008681 ()


  • Basic intravenous administration set, noninvasive
Zip E® Knotless Tissue Repair and Attachment Devices- Rb41-S-4 , # 4 resorbable captures/capture holster, 2 #2 USP UHMWPE braided suture, two thermoplastic tip covers
ZIPTEK LLC
Rb41-S-4
In Commercial Distribution

  • 00858816006064 ()
64

  • Tendon/ligament bone anchor, bioabsorbable
Corning CellSTACK Filling Accessory, two T-Manifold, tubing, Sterile, 1 per bag, 2 per case. With 12 additional Body plugs per bag; (24 per case total)
Corning Incorporated
11140
In Commercial Distribution

  • H108111403 ()
  • H108111401 ()
11140

  • Blood/tissue storage/culture container
TWINFIX 6.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADED ULTRABRAID SUTURES ONE ULTRABRAID WHITE SUTURE AND ONE ULTRABRAID COBRAID SUTURE WITH NEEDLES, STERILE
Smith & Nephew, Inc.
7210709
In Commercial Distribution

  • 03596010532213 ()
7210709

  • Tendon/ligament bone anchor, bioabsorbable
TWINFIX 5.0 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADED ULTRABRAID SUTURES ONE ULTRABRAID WHITE SUTURE AND ONE ULTRABRAID COBRAID SUTURE WITH NEEDLES, STERILE
Smith & Nephew, Inc.
7210708
In Commercial Distribution

  • 03596010532206 ()
7210708

  • Tendon/ligament bone anchor, non-bioabsorbable
TWINFIX 3.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADED ULTRABRAID SUTURES WITH NEEDLES ONE ULTRABRAID WHITE SUTURE AND ONE ULTRABRAID COBRAID SUTURE, STERILE
Smith & Nephew, Inc.
7210707
In Commercial Distribution

  • 03596010532190 ()
7210707

  • Tendon/ligament bone anchor, non-bioabsorbable
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