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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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N/A - 00614138111578

FINGER SPLINT 1/2IN X 9IN 24/BX
TETRA MEDICAL SUPPLY CORP.
149901
In Commercial Distribution

  • 00614138111578 ()
149901

  • Hand/finger splint, reusable

DynaRide Reclining Wheelchair - 00616784024912

DynaRide Reclining Wheelchair with Elevating Leg Rest 24"
Dynarex Corporation
10249
In Commercial Distribution

  • 00616784024912 ()


  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

SOFT SHIELD® Collagen Shields - 00845819005774

SOFT SHIELD® Collagen Shield, 24 Hours (CE)
OASIS MEDICAL, INC.
7024
In Commercial Distribution

  • 10845819005771 ()
  • 00845819005774 ()


  • Epithelial-resurfacing corneal shield

Abdominal Binder - 00616784438023

Abdominal Binder, Small, 12", Fits 24"-30" Waist
Dynarex Corporation
4380
In Commercial Distribution

  • 00616784438030 ()
  • 00616784438023 ()


  • Abdominal binder, reusable

Abdominal Binder - 00616784437521

Abdominal Binder, Small, 9", Fits 24"x30" waist
Dynarex Corporation
4375
In Commercial Distribution

  • 00616784437538 ()
  • 00616784437521 ()


  • Abdominal binder, reusable

Good Sense - 00846036007701

12" x 24" Deluxe Moist/Dry Heating Pad
GEISS, DESTIN & DUNN, INC
69-510
In Commercial Distribution

  • 10846036007708 ()
  • 00846036007701 ()


  • Electric pad localized-body heating system

DynaCare Disposable Underpads, Compressed Packing 2-Ply Tissue Fill - 00616784134024

17" x 24" (43 CM x 61 CM )
Dynarex Corporation
1340
In Commercial Distribution

  • 00616784134031 ()
  • 00616784134024 ()
  • 00616784134017 ()


  • Absorbent underpad, non-antimicrobial, single-use

MaxFuse,VBR, 12 (D) x 14 (W) x 24 (H) - 00846468056100

12 (D) x 14 (W) x 24 (H)
Pioneer Surgical Technology, Inc.
62-1517-36
Not in Commercial Distribution

  • 00846468056100 ()
62-1517-36

  • Vertebral body prosthesis

MaxFuse VBR, 10 (D) x 12 (W) x 24 (H) - 00846468055035

10 (D) x 12 (W) x 24 (H)
Pioneer Surgical Technology, Inc.
62-1012-37
Not in Commercial Distribution

  • 00846468055035 ()
62-1012-37

  • Vertebral body prosthesis

MaxFuse VBR, 10 (D) x 12 (W) x 24 (H) - 00846468055028

10 (D) x 12 (W) x 24 (H)
Pioneer Surgical Technology, Inc.
62-1012-36
Not in Commercial Distribution

  • 00846468055028 ()
62-1012-36

  • Vertebral body prosthesis

Irix-A Lumbar Integrated Fusion System - M697T08042301924TR1

42 X 30 X 19mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423019-24TR
In Commercial Distribution

  • M697T08042301924TR0 ()
  • M697T08042301924TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 19mm height, 24 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301724TR1

42 X 30 X 17mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423017-24TR
In Commercial Distribution

  • M697T08042301724TR0 ()
  • M697T08042301724TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 17mm height, 24 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301524TR1

42 X 30 X 15mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423015-24TR
In Commercial Distribution

  • M697T08042301524TR0 ()
  • M697T08042301524TR1 ()

  • 30mm depth X 15mm height, 24 DEG TRIAL
  • Width: 42 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08038281920TR1

33 X 26 X 15mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-382819-20TR
In Commercial Distribution

  • M697T08038281920TR0 ()
  • M697T08038281920TR1 ()

  • Width: 33 Millimeter
  • 26mm depth X 15mm height, 24 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08038281724TR1

33 X 26 X 19mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-382817-24TR
In Commercial Distribution

  • M697T08038281724TR0 ()
  • M697T08038281724TR1 ()

  • Width: 33 Millimeter
  • 26mm depth X 19mm height, 24 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08038281720TR1

33 X 26 X 13mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-382817-20TR
In Commercial Distribution

  • M697T08038281720TR0 ()
  • M697T08038281720TR1 ()

  • Width: 33 Millimeter
  • 26mm depth X 13mm height, 24 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08038281524TR1

33 X 26 X 17mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-382815-24TR
In Commercial Distribution

  • M697T08038281524TR0 ()
  • M697T08038281524TR1 ()

  • 26mm depth X 17mm height, 24 DEG TRIAL
  • Width: 33 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08033261924TR1

33 X 26 X 19mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-332619-24TR
In Commercial Distribution

  • M697T08033261924TR0 ()
  • M697T08033261924TR1 ()

  • 26mm depth X 19mm height, 24 DEG TRIAL
  • Width: 33 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08033261724TR1

33 X 26 X 17mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-332617-24TR
In Commercial Distribution

  • M697T08033261724TR0 ()
  • M697T08033261724TR1 ()

  • 26mm depth X 17mm height height, 24 DEG TRIAL
  • Width: 33 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08033261524TR1

33 X 26 X 15mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-332615-24TR
In Commercial Distribution

  • M697T08033261524TR0 ()
  • M697T08033261524TR1 ()

  • 26mm depth X 15mm height, 24 DEG TRIAL
  • Width: 33 Millimeter


  • Spinal implant trial
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