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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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MAXROM RING-LOC +5 PROVISIONAL - 00880304301795

No Description
Biomet Orthopedics, LLC
31-105951
In Commercial Distribution

  • 00880304301795 ()
31-105951

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304300002

No Description
Biomet Orthopedics, LLC
31-103918
In Commercial Distribution

  • 00880304300002 ()
31-103918

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299993

No Description
Biomet Orthopedics, LLC
31-103917
In Commercial Distribution

  • 00880304299993 ()
31-103917

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299986

No Description
Biomet Orthopedics, LLC
31-103916
In Commercial Distribution

  • 00880304299986 ()
31-103916

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299979

No Description
Biomet Orthopedics, LLC
31-103915
In Commercial Distribution

  • 00880304299979 ()
31-103915

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299962

No Description
Biomet Orthopedics, LLC
31-103914
In Commercial Distribution

  • 00880304299962 ()
31-103914

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299955

No Description
Biomet Orthopedics, LLC
31-103913
In Commercial Distribution

  • 00880304299955 ()
31-103913

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299948

No Description
Biomet Orthopedics, LLC
31-103912
In Commercial Distribution

  • 00880304299948 ()
31-103912

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299931

No Description
Biomet Orthopedics, LLC
31-103911
In Commercial Distribution

  • 00880304299931 ()
31-103911

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299924

No Description
Biomet Orthopedics, LLC
31-103910
In Commercial Distribution

  • 00880304299924 ()
31-103910

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299917

No Description
Biomet Orthopedics, LLC
31-103909
In Commercial Distribution

  • 00880304299917 ()
31-103909

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299900

No Description
Biomet Orthopedics, LLC
31-103908
In Commercial Distribution

  • 00880304299900 ()
31-103908

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299894

No Description
Biomet Orthopedics, LLC
31-103907
In Commercial Distribution

  • 00880304299894 ()
31-103907

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299887

No Description
Biomet Orthopedics, LLC
31-103906
In Commercial Distribution

  • 00880304299887 ()
31-103906

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299870

No Description
Biomet Orthopedics, LLC
31-103905
In Commercial Distribution

  • 00880304299870 ()
31-103905

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299863

No Description
Biomet Orthopedics, LLC
31-103904
In Commercial Distribution

  • 00880304299863 ()
31-103904

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299856

No Description
Biomet Orthopedics, LLC
31-103903
In Commercial Distribution

  • 00880304299856 ()
31-103903

  • Acetabulum prosthesis trial, prefabricated, reusable

IMPLANT STYLE +5 RING-LOC - 00880304299849

No Description
Biomet Orthopedics, LLC
31-103902
In Commercial Distribution

  • 00880304299849 ()
31-103902

  • Acetabulum prosthesis trial, prefabricated, reusable

2410 5 WAY STOPCOCK - 00874750009572

2410C 5W STCK.625 1.375/1.125
HANS RUDOLPH, INC.
2410
Not in Commercial Distribution

  • 00874750009572 ()
112669

  • Pulmonary function valve

2410 5 WAY STOPCOCK - 00874750009565

2410B 5W STCK.625FB 1.125/22MM
HANS RUDOLPH, INC.
2410
Not in Commercial Distribution

  • 00874750009565 ()
112668

  • Pulmonary function valve

2420 5 WAY STOPCOCK - 00874750009541

2420C 5W STPCK 22/15MM
HANS RUDOLPH, INC.
2420
Not in Commercial Distribution

  • 00874750009541 ()
112666

  • Pulmonary function valve

2420 5 WAY STOPCOCK - 00874750009527

2420A 5W STPCK 10.5/7.5MM
HANS RUDOLPH, INC.
2420
Not in Commercial Distribution

  • 00874750009527 ()
112664

  • Pulmonary function valve

2460 5 WAY STOPCOCK - 00874750009503

2460B 5W STCK.187FB 10.5/7.5MM
HANS RUDOLPH, INC.
2460
Not in Commercial Distribution

  • 00874750009503 ()
112662

  • Pulmonary function valve

2400 5 WAY STOPCOCK - 00874750008377

2400B 5 WAY STPCK 1.125ODPORTS
HANS RUDOLPH, INC.
2400
Not in Commercial Distribution

  • 00874750008377 ()
112255

  • Pulmonary function valve

2400 5 WAY STOPCOCK - 00874750008360

2400A 5W STPCK 22MM/.75 PORTS
HANS RUDOLPH, INC.
2400
Not in Commercial Distribution

  • 00874750008360 ()
112254

  • Pulmonary function valve

2410 5 WAY STOPCOCK - 00874750009558

2410A 5W STPCK.625FB 22MM/.75
HANS RUDOLPH, INC.
2410
Not in Commercial Distribution

  • 00874750009558 ()
112667

  • Pulmonary function valve

2420 5 WAY STOPCOCK - 00874750009534

2420B 5W STPCK 15/10.5MM
HANS RUDOLPH, INC.
2420
Not in Commercial Distribution

  • 00874750009534 ()
112665

  • Pulmonary function valve

2460 5 WAY STOPCOCK - 00874750009510

2460C 5W STCK.187FB 15/10.5MM
HANS RUDOLPH, INC.
2460
Not in Commercial Distribution

  • 00874750009510 ()
112663

  • Pulmonary function valve

2460 5 WAY STOPCOCK - 00874750009497

2460A 5W STCK.187FB 7.5MM/.187
HANS RUDOLPH, INC.
2460
Not in Commercial Distribution

  • 00874750009497 ()
112661

  • Pulmonary function valve

2400 5 WAY STOPCOCK - 00874750008384

2400C 5WAY STPCK 1.375ODPORTS"
HANS RUDOLPH, INC.
2400
Not in Commercial Distribution

  • 00874750008384 ()
112256

  • Pulmonary function valve

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

ROSC-U, Disposables Pack (5) - 00860000876247

Disposables Pack, 5 ea of XL Torso Restraints and Head Stabilizer Covers
RESUSCITATION INTERNATIONAL, LLC
A02-60-134
In Commercial Distribution

  • 00860000876247 ()
A02-60-134

  • Cardiac resuscitator, battery-powered

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

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
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