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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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EndoPilot Obtura set - 04260482991128

EndoPilot Obtura expansion set consist of: 1x BackFill Gun Obtura, 1x Obtura Needle Lock Nut, 4x Heat Insulator, 5x Gun-Needle Ø 25 ga, 100x Gutta Percha Bar, Accessory tools
Schlumbohm GmbH & Co. KG
v01
In Commercial Distribution

  • 04260482991128 ()
110 0133-US

  • Endodontic obturation system
  • Synthetic gutta-percha

QuickScan 2000 (Windows 2000) Software and Computer, Version 2.01 - M52516790000

No Description
HELENA LABORATORIES CORPORATION
1679000
In Commercial Distribution

  • M52516790000 ()


  • Densitometry analyser IVD

Alinity - 00380740132705

Alinity Reagent Replacement Caps
ABBOTT LABORATORIES
04R4701
In Commercial Distribution

  • 00380740132705 ()
  • 00380740163488 ()
04R4701

  • Chemiluminescent immunoassay analyser IVD
  • Multiple clinical chemistry analyser IVD, laboratory

Alinity - 00380740132699

Alinity ci-series Calibrator/Control Replacement Caps
ABBOTT LABORATORIES
04R1001
In Commercial Distribution

  • 00380740132699 ()
  • 00380740163495 ()
04R1001

  • Multiple clinical chemistry analyser IVD, laboratory
  • Chemiluminescent immunoassay analyser IVD

ARCHITECT - 00380740012465

ABBOTT ARCHITECT Sample Cups
ABBOTT LABORATORIES
7C14-01
In Commercial Distribution

  • 00380740012465 ()
  • 00380740151096 ()
07C1401

  • Multiple clinical chemistry analyser IVD, laboratory
  • Chemiluminescent immunoassay analyser IVD

Alinity - 00380740129675

Alinity ci-series Sample Cups
ABBOTT LABORATORIES
01R3801
In Commercial Distribution

  • 00380740129675 ()
  • 00380740163464 ()
01R3801

  • Chemiluminescent immunoassay analyser IVD
  • Multiple clinical chemistry analyser IVD, laboratory

Alinity - 00380740129026

Alinity Reaction Vessels
ABBOTT LABORATORIES
06P1401
In Commercial Distribution

  • 00380740129026 ()
  • 00380740163457 ()
06P1401

  • Chemiluminescent immunoassay analyser IVD
  • Multiple clinical chemistry analyser IVD, laboratory

Ray 1 - 00627987231151

Ray 1 is a portable hyperspectral imaging tool that allows qualified healthcare professionals, to assess wounds, at the point of care: i) to capture and digitally record images of fluorescence emitted from a wound when exposed to excitation light and ii) to capture and digitally record images through measuring surface temperature distribution.
Swift Medical Inc
SV403
In Commercial Distribution

  • 00627987231151 ()


  • Infrared thermography system
  • Fluorescence wound imaging unit

PEEK Replacement O-Ring for 2.7mmD Hex Tools (2 pieces) - 10841307122296

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
PEEK-2.7
In Commercial Distribution

  • 10841307122296 ()
  • 00841307122299 ()
PEEK-2.7

  • Surgical screwdriver, reusable

PEEK Replacement O-Ring for 2.3mmD Hex Tools (2 pieces) - 10841307122289

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
PEEK-2.3
In Commercial Distribution

  • 10841307122289 ()
  • 00841307122282 ()
PEEK-2.3

  • Surgical screwdriver, reusable
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