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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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Saturn 5 Laser System - 05060488041693

Assisted Reproduction Laser
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active - Nikon Ti with Integra 40x
In Commercial Distribution

  • 05060488041693 ()
6-47-500-01

  • Assisted reproduction laser system

Saturn 5 Laser System - 05060488044915

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

Saturn 5 Laser System - 05060488043628

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

  • 05060488043628 ()
6-47-500-23

  • Assisted reproduction laser system

Saturn 5 Laser System - 05060488043406

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

  • 05060488043406 ()
6-47-501-03

  • Assisted reproduction laser system

Saturn 5 Laser System - 05060488042751

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

  • 05060488042751 ()
6-47-500-18

  • Assisted reproduction laser system

Saturn 5 Laser System - 05060488042744

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

  • 05060488042744 ()
6-47-500-17

  • Assisted reproduction laser system

Saturn 5 Laser System - 05060488042737

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

Forceps Jewellers #5 Angled - 05060745552320

No Description
BLINK MEDICAL LIMITED
11-2005
In Commercial Distribution

  • 05060745552320 ()
  • 05060745552337 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, single-use

TISSUE FORCEPS SERRATED 5" - D9281300040

No Description
W.H. Holden, Inc.
13-0004
In Commercial Distribution

  • D9281300040 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Peezo Reamers, 5, 32 - 05060940375663

No Description
ENDOPERFECTION LIMITED
ESP325
In Commercial Distribution

  • 05060940375663 ()


  • Endodontic enlarger, reusable

Peezo Reamers, 5, 28 - 05060940375595

No Description
ENDOPERFECTION LIMITED
ESP285
In Commercial Distribution

  • 05060940375595 ()


  • Endodontic enlarger, reusable

Gates Gliddens, 5, 32 - 05060940375526

No Description
ENDOPERFECTION LIMITED
ESG325
In Commercial Distribution

  • 05060940375526 ()


  • Endodontic enlarger, reusable

Gates Gliddens, 5, 28 - 05060940375458

No Description
ENDOPERFECTION LIMITED
ESG285
In Commercial Distribution

  • 05060940375458 ()


  • Endodontic enlarger, reusable

Barbed Broaches, 5, 25 - 05060940375373

No Description
ENDOPERFECTION LIMITED
HSB255
In Commercial Distribution

  • 05060940375373 ()


  • Endodontic broach, serrated, reusable

Barbed Broaches, 5, 21 - 05060940375281

No Description
ENDOPERFECTION LIMITED
HSB215
In Commercial Distribution

  • 05060940375281 ()


  • Endodontic broach, serrated, reusable

TOWEL CLAMP BACKHAUS 5" - D9281071750

No Description
W.H. Holden, Inc.
10-7175
In Commercial Distribution

  • D9281071750 ()


  • Towel clamp, reusable

CURVED FORCEPS SMOOTH 5" - D9281059520

No Description
W.H. Holden, Inc.
10-5952
In Commercial Distribution

  • D9281059520 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

SKIN HOOK FRAZIER-DURA 5" - D9281057000

No Description
W.H. Holden, Inc.
10-5700
In Commercial Distribution

  • D9281057000 ()


  • Soft-tissue surgical hook, reusable

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

5 POUND SHOT WEIGHT - 00842430111693

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
351
In Commercial Distribution

  • 00842430111693 ()
351

  • Traction weight

MLPD EXTENSION POST, 5" - 00842430110252

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5875-05
In Commercial Distribution

  • 00842430110252 ()
5875-05

  • Operating table torso positioner

5 High Flow Pigtails - 00607567208568

No Description
DATASCOPE CORP.
T 50002
Not in Commercial Distribution

  • 00607567208568 ()
709000235

  • Cardiopulmonary bypass system blood tubing set

VISION 5/13 L-WRENCH - 00880304491946

No Description
Biomet Orthopedics, LLC
14270
In Commercial Distribution

  • 00880304491946 ()
14270

  • Surgical torque wrench, reusable

React Health Phoenix 5 - 06934726614439

No Description
Longfian Scitech Co., Ltd.
SOC5100
In Commercial Distribution

  • 06934726614439 ()


  • Mobile/portable oxygen concentrator

Anaesthetic Mask, Size 5# - 06923310903530

No Description
Hangzhou Formed Medical Devices Co.Ltd.
PA150205
In Commercial Distribution

  • 06923310903530 ()
PA150205

  • Anaesthesia face mask, single-use

EPIQ 5 Ultrasound System - 00884838107502

No Description
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838107502 ()


  • General-purpose ultrasound imaging system

Dorsal Columella Style 5 - M724400544S1

Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 4
In Commercial Distribution

  • M724400544S1 ()
400-544S

  • Nasal cartilage support implant, non-bioabsorbable

Dorsal Columella Style 5 - M724400534S1

Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 3
In Commercial Distribution

  • M724400534S1 ()
400-534S

  • Nasal cartilage support implant, non-bioabsorbable

Dorsal Columella Style 5 - M724400524S1

Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 2
In Commercial Distribution

  • M724400524S1 ()
400-524S

  • Nasal cartilage support implant, non-bioabsorbable

Dorsal Columella Style 5 - M724400514S1

Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 1
In Commercial Distribution

  • M724400514S1 ()
400-514S

  • Nasal cartilage support implant, non-bioabsorbable

FJ Clip Neo 5 - 00883475954753

No Description
CHARMANT INC.
24-0003
In Commercial Distribution

  • 00883475954753 ()


  • Gastrointestinal endoscopic clip applier

SAFECUP III MULTIDRUG 5 - 00695684454753

No Description
GERMAINE LABORATORIES, INC
45475
In Commercial Distribution

  • 00695684454753 ()
  • 00695684454751 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical

SAFECUP II MULTIDRUG 5 - 00695684454654

Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, mAMP, AMP, THC, OPI, (cocaine, methamphetamine, amphetamine, marijuana, opiates).
GERMAINE LABORATORIES, INC
45465
In Commercial Distribution

  • 00695684454654 ()
  • 00695684454651 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

STA® - Fibrinogen 5 - 13607450006749

No Description
DIAGNOSTICA STAGO
00674
In Commercial Distribution

  • 13607450006749 ()
  • 03607450006742 ()


  • Fibrinogen assay (factor I) IVD, kit, clotting

MOSAIC INSTRUMENT CASE #5 - 00880304397149

No Description
Biomet Orthopedics, LLC
595151
In Commercial Distribution

  • 00880304397149 ()
595151

  • Instrument tray, reusable

DISCOVERY ELBOW 5 STEP - 00880304370333

No Description
Biomet Orthopedics, LLC
414912
In Commercial Distribution

  • 00880304370333 ()
414912

  • Bone-resection orthopaedic reamer, reusable

PAR 5 HIP SYSTEM - 00880304197404

No Description
Biomet Orthopedics, LLC
109272
In Commercial Distribution

  • 00880304197404 ()

  • 72 MM 26 LINER SIZE
109272

  • Acetabular shell

PAR 5 HIP SYSTEM - 00880304197381

No Description
Biomet Orthopedics, LLC
109268
In Commercial Distribution

  • 00880304197381 ()

  • 68 MM 25 LINER SIZE
109268

  • Acetabular shell

PAR 5 HIP SYSTEM - 00880304197374

No Description
Biomet Orthopedics, LLC
109264
In Commercial Distribution

  • 00880304197374 ()

  • 64 MM 24 LINER SIZE
109264

  • Acetabular shell

PAR 5 HIP SYSTEM - 00880304197350

No Description
Biomet Orthopedics, LLC
109260
In Commercial Distribution

  • 00880304197350 ()

  • 60 MM 23 LINER SIZE
109260

  • Acetabular shell

PAR 5 HIP SYSTEM - 00880304197343

No Description
Biomet Orthopedics, LLC
109256
In Commercial Distribution

  • 00880304197343 ()

  • 56 MM 23 LINER SIZE
109256

  • Acetabular shell

PAR 5 HIP SYSTEM - 00880304197282

No Description
Biomet Orthopedics, LLC
109220
In Commercial Distribution

  • 00880304197282 ()
109220

  • Coated hip femur prosthesis, modular

Abacus 5 Hematology Analyzer - 05999883586228

Abacus 5 is an automated differential cell counter device used to identify one or more of the formed elements of the blood. The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters in K3EDTA anti-coagulated venous whole blood samples: WBC, LYM%, LYM#, MON%, MON#, NEU%, NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV,MCH, MCHC, RDWcv, RDWsd, PCT, PDWcv, PDWsd, PLT, MPV, PLCC, and PLCR.
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Abacus 5
In Commercial Distribution

  • 05999883586228 ()
  • 15999883586225 ()

  • Depth: 493 Millimeter
  • Width: 410 Millimeter
  • Height: 520 Millimeter
A5US-1

  • Haematological cell analyser IVD

PAR 5 RING-LOC ACETABULAR - 00880304303904

No Description
Biomet Orthopedics, LLC
31-109272
In Commercial Distribution

  • 00880304303904 ()
31-109272

  • Acetabulum prosthesis trial, prefabricated, reusable

PAR 5 RING-LOC ACETABULAR - 00880304303898

No Description
Biomet Orthopedics, LLC
31-109268
In Commercial Distribution

  • 00880304303898 ()
31-109268

  • Acetabulum prosthesis trial, prefabricated, reusable

PAR 5 RING-LOC ACETABULAR - 00880304303881

No Description
Biomet Orthopedics, LLC
31-109264
In Commercial Distribution

  • 00880304303881 ()
31-109264

  • Acetabulum prosthesis trial, prefabricated, reusable

PAR 5 RING-LOC ACETABULAR - 00880304303874

No Description
Biomet Orthopedics, LLC
31-109260
In Commercial Distribution

  • 00880304303874 ()
31-109260

  • Acetabulum prosthesis trial, prefabricated, reusable

PAR 5 RING-LOC ACETABULAR - 00880304303867

No Description
Biomet Orthopedics, LLC
31-109256
In Commercial Distribution

  • 00880304303867 ()
31-109256

  • Acetabulum prosthesis trial, prefabricated, reusable
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