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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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Boston Keratoprosthesis Snap-on TypeI 8.5 mm Titanium Back Plate.
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
TSO-8.5
In Commercial Distribution

  • 00862394000246 ()

  • Outer Diameter: 8.5 Millimeter
TSO-8.5

  • Cornea prosthesis
Boston Keratoprosthesis Snap-on TypeI 7mm PMMA Back Plate
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
SO-7
In Commercial Distribution

  • 00862394000239 ()

  • Outer Diameter: 7 Millimeter
SO-7

  • Cornea prosthesis
Boston Keratoprosthesis, Snap-on TypeI. 8.5 mm PMMA Back Plate.
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
SO-8.5
In Commercial Distribution

  • 00862394000222 ()

  • Outer Diameter: 8.5 Millimeter
SO-8.5

  • Cornea prosthesis
The Boston Keratoprosthesis ( KPro) Snap-on TypeI, PMMA Aphakia
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
SOF-T15P
In Commercial Distribution

  • 00862394000215 ()

  • Outer Diameter: 5 Millimeter
SOF-T15P

  • Cornea prosthesis
The Boston Keratoprosthesis Snap-on TypeI Aphakia
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
SOF-TI5A
In Commercial Distribution

  • 00862394000208 ()

  • Outer Diameter: 5 Millimeter
SOF-TI5A

  • Cornea prosthesis
Tubal Occluding Device in a sterile pouch (2 Hulka Clips per pouch)
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
4986.90
Not in Commercial Distribution

  • 00861523000102 ()
  • 10861523000109 ()
4986.09

  • Fallopian tube clip/band
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
One pouched device, 1F001
Safepath Medical, Inc.
1F001
Not in Commercial Distribution

  • 00861298002608 ()
1F001

  • Silk suture
Membrane Placement Inst, Black Line
HU-FRIEDY MFG. CO., LLC
PMPIX
In Commercial Distribution

  • 10889950019723 ()
PMPIX

  • Dental implant system
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