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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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mi-tablet 2 - 00857356008064

Tablet for use as part of the mi-eye 2 System.
TRICE MEDICAL, INC.
T200-020
Not in Commercial Distribution

  • 00857356008064 ()


  • Rigid optical arthroscope, single-use

mi-eye 2 - 00857356008026

MI-EYE 2 SYSTEM, MI-ULTRA, EN
TRICE MEDICAL, INC.
T200-010
Not in Commercial Distribution

  • 00857356008026 ()


  • Rigid optical arthroscope, single-use

QuickRay #2 - 00858475006085

Intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.
DENTERPRISE INTERNATIONAL, INC.
e2V Size #2
In Commercial Distribution

  • 00858475006085 ()


  • Dental digital imaging sensor, intraoral

Pachmate 2 - 00857377006001

The DGH 55B is a Handheld Ultrasonic Pachymeter. It is a hand-held, battery-powered electronic medical device that uses ultrasonic pulse technology to measure the thickness of the human cornea.
DGH TECHNOLOGY INC.
DGH 55B
In Commercial Distribution

  • 00857377006001 ()


  • Ultrasound pachymeter

Standard 2 - 00657498001790

To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas Chemistry Systems.
STANBIO LABORATORY, L.P.
A469-98
Not in Commercial Distribution

  • 00657498001790 ()
A469-98

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

KneeAlign 2 - 00858704006800

KneeAlign 2 Instrument Kit
Orthalign, Inc.
402064-09
In Commercial Distribution

  • 00858704006800 ()
402064-09

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006510

Button Cap, Black
Orthalign, Inc.
402047-03
In Commercial Distribution

  • 00858704006510 ()
402047-03

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006503

Button Cap, White
Orthalign, Inc.
402046-08
In Commercial Distribution

  • 00858704006503 ()
402046-08

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006480

Femoral Drill Guide, Neutral
Orthalign, Inc.
402418
In Commercial Distribution

  • 00858704006480 ()
402418

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006459

Threaded Pin, Headless, 65mm
Orthalign, Inc.
402069
In Commercial Distribution

  • 00858704006459 ()
  • 00851977007161 ()
402069

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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