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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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CUSA® Selector® 35KHz Neuro Flue (Pack of 5)
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523162
Not in Commercial Distribution

  • M27315231621 ()
  • 10381780121930 ()
  • 00381780121933 ()

  • 35kHz Ultrasonic Frequency
1523162

  • Ultrasonic surgical system flue
CUSA® Selector® 24KHz Neuro long Flue(Pack of 20)
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523047
Not in Commercial Distribution

  • M27315230471 ()
  • 10381780121923 ()
  • 00381780121926 ()

  • 24kHz Ultrasonic Frequency
1523047

  • Ultrasonic surgical system flue
USP Sterile Water, 100 mL Bottle
NURSE ASSIST, INC.
6492776
In Commercial Distribution

  • B15064927764 ()
  • B15064927760 ()


  • Wound irrigation sterile water
USP Normal Saline, 100 mL Bottle
NURSE ASSIST, INC.
6492775
In Commercial Distribution

  • B15064927750 ()
  • B15064927754 ()


  • Non-antimicrobial wound irrigation solution, saline
Absorbable Wound Dressing 10mm x 20mm.
COLLAGEN MATRIX, INC.
0102Z
In Commercial Distribution

  • M4400102Z1 ()
  • 00813954020457 ()


  • General oral wound dressing, animal-derived
Absorbable Wound Dressing 2cm x 4cm.
COLLAGEN MATRIX, INC.
0101Z
In Commercial Distribution

  • M4400101Z1 ()
  • 00813954020440 ()


  • General oral wound dressing, animal-derived
Absorbable Wound Dressing 10mm x 20mm.
COLLAGEN MATRIX, INC.
0100Z
In Commercial Distribution

  • M4400100Z1 ()
  • 00813954020433 ()


  • General oral wound dressing, animal-derived
The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary canal of the phalanx. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012016
Not in Commercial Distribution

  • M2480120161 ()
  • 10381780065487 ()

  • .816 in dia x .662 in L; Size 3
012016

  • Partial metatarsophalangeal joint prosthesis
The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary canal of the phalanx. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012014
Not in Commercial Distribution

  • M2480120141 ()
  • 10381780065470 ()

  • .776 in dia x .662 in L; Size 2
012014

  • Partial metatarsophalangeal joint prosthesis
The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary canal of the phalanx. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012012
Not in Commercial Distribution

  • M2480120121 ()
  • 10381780065463 ()

  • .734 in dia x .662 in L; Size 1
012012

  • Partial metatarsophalangeal joint prosthesis
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