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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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VITROS - 10758750035069

VITROS Immunodiagnostic Products Syphilis Calibrator
ORTHO CLINICAL DIAGNOSTICS
6177334
In Commercial Distribution

  • 20758750035066 ()
  • 10758750035069 ()
6177334

  • Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay

SleepmatePressure Airflow - Alice 5 - 05707480041756

Ref. 14841
Ambu A/S
814300-021
In Commercial Distribution

  • 05707480041756 ()
814300-021

  • Polysomnograph

Test Chamber, Pack 5 - 00850039020162

No Description
Medical Technical Products, Inc.
23-9004
In Commercial Distribution

  • 00850039020162 ()


  • Anterior chamber physical simulator

Saturn 5 Laser System - 05060170183793

Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Laser System with RI Viewer Software
In Commercial Distribution

  • 05060170183793 ()
6-47-500

  • Assisted reproduction laser system

Saturn 5 Laser System - 05060170183786

Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Laser System Fixed with RI Viewer Software
In Commercial Distribution

  • 05060170183786 ()
6-47-501

  • Assisted reproduction laser system

Buprenorphine 5 Control Set - 00850624008063

BUP 5 Negative Control 3 ng/mL (2 x 15 mL), BUP 5 Positive Control 7 ng/mL (2 x 15 mL).
LIN-ZHI INTERNATIONAL, INC.
08356670190
In Commercial Distribution

  • 00850624008063 ()
08356670190

  • Buprenorphine IVD, control

Global Reference Module 5 - 00850011306550

The Global Reference Module 5 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 5
In Commercial Distribution

  • 00850011306550 ()
31-0604-0047

  • Electroencephalographic signal amplifier

DUST BARRIER, 5 PACK - 00850010197234

No Description
QUINTRON INSTRUMENT COMPANY, INC.
QT01140-K
In Commercial Distribution

  • 00850010197869 ()
  • 00850010197234 ()
QT01140-K

  • Gas chromatography analyser IVD

Compass Chair Size 5 - 00850001752206

Classroom chair
RIFTON EQUIPMENT
R350
In Commercial Distribution

  • 00850001752206 ()


  • Assistive ergonomic chair, manually-adjusted

SET STUDENTS BAUSA 5 - J00717007941001

SET of different CA & HP supplied for students.
Bien-Air Dental SA
1700794-001
In Commercial Distribution

  • J00717007941001 ()
1700794-001

  • Dental power tool system handpiece, remotely-driven
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