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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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LDPE Specimine Containers, 16 & 32 Oz, Sterile
SPECTRUM, INC.
987-03741-000
In Commercial Distribution

  • 10850301007812 ()
  • 00850301007815 ()
725300

  • General specimen container IVD, no additive, sterile
Specimin Container, 32 Oz, Sterile
SPECTRUM, INC.
987-03923-000
In Commercial Distribution

  • 10850301007799 ()
  • 00850301007792 ()
725100

  • General specimen container IVD, no additive, sterile
For Use with DonorScreen-HLA Class I and Class II
IMMUCOR GTI DIAGNOSTICS, INC.
404563
In Commercial Distribution

  • 10888234500483 ()
404563

  • HLA class I & II antibody screening IVD, reagent
For Red Blood Cell Exchange (RBCX) Procedures. For use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6C2172
In Commercial Distribution

  • 04052682031724 ()
  • 14052682031721 ()
X6C2172

  • Blood transfer set
FIXCET SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
X063-0025
In Commercial Distribution

  • M697X06300250 ()
  • M697X06300251 ()


  • Surgical screwdriver, reusable
SCREWDRIVER SHAFT ASSY, SHORT
Xtant Medical Holdings, Inc.
T076-0064
In Commercial Distribution

  • M697T07600640 ()
  • M697T07600641 ()


  • Surgical screwdriver, reusable
SCREWDRIVER SHAFT ASSY, LONG
Xtant Medical Holdings, Inc.
T076-0063
In Commercial Distribution

  • M697T07600630 ()
  • M697T07600631 ()


  • Surgical screwdriver, reusable
Hexalobe Driver
Life Spine, Inc.
144-017
In Commercial Distribution

  • 00190837041205 ()
144-017

  • Surgical screwdriver, reusable
Facet Screw Driver
Life Spine, Inc.
144-015
In Commercial Distribution

  • 00190837041199 ()
144-015

  • Surgical screwdriver, reusable
Screw driver, self-retaining Cannulated (Hex holding type)
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039825474 ()
FA.IC.7002

  • Surgical screwdriver, reusable
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