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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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Tandem Mobi Adhesive Sleeve - 00389152076157

No Description
Tandem Diabetes Care, Inc.
1010123
In Commercial Distribution

  • 00389152000961 ()
  • 00389152076157 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Pristina Paddle - 00195278925428

Small Square presurgical localization paddle - Labelled
GE MEDICAL SYSTEMS
SLD LS
In Commercial Distribution

  • 00195278925428 ()


  • Stationary mammographic x-ray system, digital

Simulator II - 10850390007137

A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Sim II 03
In Commercial Distribution

  • 10850390007137 ()


  • Biomechanical function analysis system, force-testing, stationary

MagStand 1.5 - 00840682138826

No Description
GE MEDICAL SYSTEMS
MAG5
In Commercial Distribution

  • 00840682138826 ()


  • Stationary mammographic x-ray system, digital

MagStand 1.8 - 00840682138802

No Description
GE MEDICAL SYSTEMS
MAG8
In Commercial Distribution

  • 00840682138802 ()


  • Stationary mammographic x-ray system, digital

Simulator II - 10850390007151

A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Sim II 5
In Commercial Distribution

  • 10850390007151 ()


  • Biomechanical function analysis system, force-testing, stationary

Arthrex® - 10888867222820

O-RING, REPLACEMENT, AR-8330SJ VALVE
ARTHREX, INC.
AR-8330SJO
Not in Commercial Distribution

  • 00888867222823 ()
  • M150AR8330SJO0 ()
  • 10888867222820 ()
AR-8330SJO

  • Arthroscopic shaver system, electrically-powered

Arthrex® - 10888867043265

O-RING, REPLACEMENT, AR-8330 VALVES
ARTHREX, INC.
AR-8330VO
Not in Commercial Distribution

  • 00888867043268 ()
  • 10888867043265 ()
AR-8330VO

  • Arthroscopic shaver system, electrically-powered

Sprinter XL (model 160 samples, IFA/ELISA) - 04049016109716

No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0033-0101-6
Not in Commercial Distribution

  • 04049016109716 ()


  • Enzyme immunoassay (EIA) analyser IVD
  • Laboratory diluter

Sprinter XL (model 160 samples, IFA/ELISA incl. Incubator) - 04049016109686

No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0033-0101-3
Not in Commercial Distribution

  • 04049016109686 ()


  • Enzyme immunoassay (EIA) analyser IVD
  • Laboratory diluter
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