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

  • 00850010197869 ()
  • 00850010197234 ()
QT01140-K

  • Gas chromatography analyser IVD
Classroom chair
RIFTON EQUIPMENT
R350
In Commercial Distribution

  • 00850001752206 ()


  • Assistive ergonomic chair, manually-adjusted
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
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600386-001
In Commercial Distribution

  • J00716003860011 ()
1600386-001

  • Dental power tool system handpiece, remotely-driven
No Description
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
LG1620
In Commercial Distribution

  • 00848657075749 ()
LG1620

  • Laparoscopic surgical procedure kit, non-medicated, reusable
Conformity stem, collared, #5
UNITED ORTHOPEDIC CORP.
1110-1005
In Commercial Distribution

  • 04711605582988 ()
1110-1005

  • Metal-on-polyethylene total hip prosthesis
  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular
No Description
ENDOPERFECTION LIMITED
ESP325
In Commercial Distribution

  • 05060940375663 ()


  • Endodontic enlarger, reusable
No Description
ENDOPERFECTION LIMITED
ESP285
In Commercial Distribution

  • 05060940375595 ()


  • Endodontic enlarger, reusable
No Description
BLINK MEDICAL LIMITED
11-2005
In Commercial Distribution

  • 05060745552320 ()
  • 05060745552337 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, single-use
No Description
ENDOPERFECTION LIMITED
ESG325
In Commercial Distribution

  • 05060940375526 ()


  • Endodontic enlarger, reusable
No Description
ENDOPERFECTION LIMITED
ESG285
In Commercial Distribution

  • 05060940375458 ()


  • Endodontic enlarger, reusable
No Description
ENDOPERFECTION LIMITED
HSB255
In Commercial Distribution

  • 05060940375373 ()


  • Endodontic broach, serrated, reusable
No Description
ENDOPERFECTION LIMITED
HSB215
In Commercial Distribution

  • 05060940375281 ()


  • Endodontic broach, serrated, reusable
No Description
W.H. Holden, Inc.
10-7175
In Commercial Distribution

  • D9281071750 ()


  • Towel clamp, reusable
No Description
W.H. Holden, Inc.
10-5952
In Commercial Distribution

  • D9281059520 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
No Description
W.H. Holden, Inc.
10-5700
In Commercial Distribution

  • D9281057000 ()


  • Soft-tissue surgical hook, reusable
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Fixed for Nikon Ti2 40x
In Commercial Distribution

  • 05060488044915 ()
6-47-501-04

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active 20x Nikon Ti2 with Nikon XY Stage
In Commercial Distribution

  • 05060488044847 ()
6-47-500-28

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active 20x Nikon Ti2 with Integra
In Commercial Distribution

  • 05060488044830 ()
6-47-500-27

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active 40x Nikon Ti2 with Nikon XY Stage
In Commercial Distribution

  • 05060488044823 ()
6-47-500-26

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active 40x Nikon Ti2 with Integra
In Commercial Distribution

  • 05060488044816 ()
6-47-500-25

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Nikon TE2000 with Nikon XY Stage 20x
In Commercial Distribution

  • 05060488043789 ()
6-47-500-22

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Nikon TE2000 with Integra 20x
In Commercial Distribution

  • 05060488043772 ()
6-47-500-21

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Olympus IX50-70
In Commercial Distribution

  • 05060488043635 ()
6-47-500-24

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Nikon Diaphot200-300
In Commercial Distribution

  • 05060488043628 ()
6-47-500-23

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Fixed Leica DMi8 40x
In Commercial Distribution

  • 05060488043406 ()
6-47-501-03

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Fixed Nikon TE2000 & Ti 40x
In Commercial Distribution

  • 05060488043338 ()
6-47-501-01

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Nikon TE2000 With Integra 40x
In Commercial Distribution

  • 05060488043277 ()
6-47-500-19

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Fixed Nikon TE300 40x
In Commercial Distribution

  • 05060488042812 ()
6-47-501-02

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Nikon TE2000 with Nikon XY Stage 40x
In Commercial Distribution

  • 05060488042768 ()
6-47-500-20

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Nikon TE300 20x
In Commercial Distribution

  • 05060488042751 ()
6-47-500-18

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Nikon TE300 40x
In Commercial Distribution

  • 05060488042744 ()
6-47-500-17

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Olympus IX2 20x RH
In Commercial Distribution

  • 05060488042737 ()
6-47-500-16

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Olympus IX2 40x RH
In Commercial Distribution

  • 05060488042720 ()
6-47-500-15

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Olympus IX2 20x LH
In Commercial Distribution

  • 05060488042713 ()
6-47-500-14

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Olympus IX2 40x LH
In Commercial Distribution

  • 05060488042706 ()
6-47-500-13

  • Assisted reproduction laser system
Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active Zeiss Axio Observer 20x RH
In Commercial Distribution

  • 05060488042690 ()
6-47-500-12

  • Assisted reproduction laser system
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