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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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Zimmer, Inc.
00-5917-020-10
In Commercial Distribution

  • 00889024665118 ()

  • Size A B 10 mm Height
00-5917-020-10

  • Tibial insert
The Catheter Revision Kit is a sterile kit designed to facilitate the replacement of a section of the intrathecal catheter. A replacement catheter segment is provided with a catheter connector (and sleeve) to allow this segment to be attached to the existing catheter.
Flowonix Medical, Inc.
11830
In Commercial Distribution

  • 00810335020105 ()


  • Spinal infusion/drainage catheter
The Model 2004 Implant Kit consists of a Model 2002 Rechargeable Neuroregulator (including Model 1680 Torque Wrench), a Model 2200P-47E Maestro Posterior Lead, and a Model 2200A-47E Anterior Lead packaged together.
Reshape Lifesciences Inc.
2004
Not in Commercial Distribution

  • 00857334004279 ()
2004

  • Gastric contractility modulation system
A microscope used to screen ThinPrep® pap test slides that have been imaged by a ThinPrep® Image Processor.
Hologic, Inc.
ThinPrep Imaging System Review Scope
In Commercial Distribution

  • 15420045500891 ()
71062-001

  • Basic light microscope
Device is a stool collection kit for at-home use.
Geneoscopy, Inc.
0
In Commercial Distribution

  • 00198715728941 ()


  • Faecal specimen collection kit IVD, home-use
SFTWR 9767 HEAD PRGMG RF TLMY SYS A/B
MEDTRONIC, INC.
9767
In Commercial Distribution

  • 00721902046940 ()


  • Cardiac pulse generator programmer
Talar A/P Cut Guide Assembly, Right, XS, XXS
Stryker GmbH
908-0266
In Commercial Distribution

  • 00886385017730 ()


  • Orthopaedic implant aiming arm
Datum Talar A/P Cut Guide Assembly, Right Small
Stryker GmbH
908-0262
In Commercial Distribution

  • 00886385017655 ()


  • Orthopaedic implant aiming arm
Talar A/P Cut Guide Assembly, Left XS, XXS
Stryker GmbH
908-0166
In Commercial Distribution

  • 00886385017495 ()


  • Orthopaedic implant aiming arm
Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with a blue sterile filter and an EASYSPRAY-Clip to be attached to the COSEAL Surgical Sealant plunger for gas activation.
BAXTER HEALTHCARE CORPORATION
1514243
In Commercial Distribution

  • 35413765583415 ()
  • 05413765583414 ()
  • 55413765583419 ()
1514243

  • Open-surgery adhesive/sealant applicator, dual-channel
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