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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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RL-500 - 08809315679817

Hose 1ea, Com cable 1ea (1 set box)
DAESUNG MAREF CO.,LTD.
1000860
In Commercial Distribution

  • 18809315679814 ()
  • 08809315679817 ()
  • 28809315679811 ()


  • Hand/wrist continuous passive motion exerciser

CoreValve™ - 00643169565623

DEL SYS DCS-C4-18F-US COM 26/29/31 NP
MEDTRONIC COREVALVE LLC
DCS-C4-18F-US
Not in Commercial Distribution

  • 00643169565623 ()


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

NAMIC - 10193489076363

MTO LEFT HEART KIT PARMA COM GEN HOSP
MEDLINE INDUSTRIES, INC.
651621415
In Commercial Distribution

  • 10193489076363 ()
651621415

  • Angiography kit

NAMIC - 10193489075151

MTO LEFT HEART W/DT BOULDER COM HOSP
MEDLINE INDUSTRIES, INC.
650305414
In Commercial Distribution

  • 10193489075151 ()
650305414

  • Angiography kit

NAMIC - 10193489071887

MTO 3 WAY MANIFOLD KIT PARMA COM GEN
MEDLINE INDUSTRIES, INC.
601621410
In Commercial Distribution

  • 20193489071884 ()
  • 10193489071887 ()
601621410

  • Angiography kit

NAMIC - 10193489063233

MTO LEFT HEART KIT SEVEN RIVERS COM HOSP
MEDLINE INDUSTRIES, INC.
65193662
In Commercial Distribution

  • 10193489063233 ()
65193662

  • Angiography kit

NAMIC - 10193489040432

MTO LEFT HEART KIT SAN ANGELO COM MED
MEDLINE INDUSTRIES, INC.
60010991
In Commercial Distribution

  • 20193489040439 ()
  • 10193489040432 ()
60010991

  • Angiography kit

Ohio - 00628101618247

50PSI PRST COM AIR GAS REG CGA346 MRI
OHIO MEDICAL, LLC
GR-346-DCXX-XXM
In Commercial Distribution

  • 00628101618247 ()
GR-346-DCXX-XXM

  • Non-fixed medical gas cylinder regulator

NORDENT MANUFACTURING INC - 00840018647244

COM PLACEM INST DE, #40-30 TIN, DL HNDL
NORDENT MANUFACTURING INC
REPFI40T-30T
In Commercial Distribution

  • 00840018647244 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018637689

COM PLACE INST DE LR 2 TIN DL-
NORDENT MANUFACTURING INC
REPFILR2T
In Commercial Distribution

  • 00840018637689 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636002

COM PLACM INST DE #5 TIN STD H
NORDENT MANUFACTURING INC
PFI5T
In Commercial Distribution

  • 00840018636002 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635975

COM PLACM INST DE #4 TIN STD H
NORDENT MANUFACTURING INC
PFI4T
In Commercial Distribution

  • 00840018635975 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635937

COM PLACM INST DE #3 TIN STD H
NORDENT MANUFACTURING INC
PFI3T
In Commercial Distribution

  • 00840018635937 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635883

COM PLACM INST DE #2 TIN STD H
NORDENT MANUFACTURING INC
PFI2T
In Commercial Distribution

  • 00840018635883 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635814

COM PLACM INST DE #1 TIN STD H
NORDENT MANUFACTURING INC
PFI1T
In Commercial Distribution

  • 00840018635814 ()


  • Margin finishing dental file/rasp, reusable

909 P37,Z4,2L,1LD,AUDIO & COM SWAP,STKR - 00840828100359

909 P37,Z4,2L,1LD,AUDIO & COM SWAP,STKR
CURBELL MEDICAL PRODUCTS, INC.
3001-990-353
In Commercial Distribution

  • 00840828100359 ()
178

  • Electrical mains power extension cable

STATION,WIRELESS READY,PULLCORD,BLUE ACT,COM,CONN - B4841166480

STATION,WIRELESS READY,PULLCORD,BLUE ACT,COM,CONN
Crest Healthcare Supply
116648
In Commercial Distribution

  • B4841166480 ()


  • Nurse call system

ABVISER - 00768455127993

ABVISER AV IAP COM W/ARGON T'DUCER, POLE
CONVATEC, PURCHASING DEPARTMENT
420760
Not in Commercial Distribution

  • 00768455127993 ()
  • 00768455128136 ()
420760

  • Intra-abdominal pressure measurement set, electronic

Anti-B (Murine Monoclonal) Series 3 - 10888234001997

Anti-B (Murine Monoclonal) Series 3 is intended for use in slide, tube, microplate and automated tests, for the detection of the B antigen.
IMMUCOR, INC.
0006407
In Commercial Distribution

  • 10888234001997 ()
0006407

  • Anti-B red blood cell grouping IVD, antibody

Anti-B (Murine Monoclonal) Gamma-clone - 10888234001720

This reagent is used in slide, tube and microplate tests, for the detection of the B antigen of the ABO blood group system. The package configuration for this product code is ten (10) vials of reagent.
IMMUCOR, INC.
0413210
In Commercial Distribution

  • 10888234001720 ()
0413210

  • Anti-B red blood cell grouping IVD, antibody

Anti-B (Murine Monoclonal) Gamma-clone - 10888234001713

This reagent is used in slide, tube and microplate tests, for the detection of the B antigen of the ABO blood group system. The package configuration for this product code is three (3) vials of reagent.
IMMUCOR, INC.
0413203
In Commercial Distribution

  • 10888234001713 ()
0413203

  • Anti-B red blood cell grouping IVD, antibody

Anti-B (Murine Monoclonal) Series 3 - 10888234000532

Anti-B (Murine Monoclonal) Series 3 is intended for use in slide, tube, microplate and automated tests, for the detection of the B antigen.
IMMUCOR, INC.
0006406
In Commercial Distribution

  • 10888234000532 ()
0006406

  • Anti-B red blood cell grouping IVD, antibody

ALBAclone Anti-B - 05060242471438

Blood Grouping Reagent, ALBAclone Anti-B (Murine Monoclonal IgM) for slide and tube techniques.
ALBA BIOSCIENCE LIMITED
Z015U
In Commercial Distribution

  • 05060242471438 ()
  • 05060242471254 ()
  • 05060242470875 ()


  • Anti-B red blood cell grouping IVD, antibody

Procleix HIV-1/HCV/HBV Quality Control - 00850032683036

Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 (HIV-1) RNA with the Procleix Ultrio Elite Assay performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HBV Positive Control
In Commercial Distribution

  • 00850032683036 ()


  • Hepatitis B virus nucleic acid IVD, control

Alinity - 00380740136802

Alinity s HBsAg Release Control Kit
Abbott Ireland Diagnostics
06P0215
In Commercial Distribution

  • 00380740136802 ()
06P0215

  • Hepatitis B virus surface antigen IVD, control

Alinity - 00380740136796

Alinity s HBsAg Assay Control Kit
Abbott Ireland Diagnostics
06P0213
In Commercial Distribution

  • 00380740136796 ()
06P0213

  • Hepatitis B virus surface antigen IVD, control

Lumipulse G B-Amyloid 1-40 Calibrator Set - 04987270234891

No Description
FUJIREBIO INC.
234891
In Commercial Distribution

  • 04987270234891 ()

  • Number of bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, calibrator

Lumipulse G B-Amyloid 1-42 Calibrator Set - 04987270234884

No Description
FUJIREBIO INC.
234884
In Commercial Distribution

  • 04987270234884 ()

  • Number of Bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, calibrator

BIOCLONE - 10758750007448

Anti-B BIOCLONE 3x10ml
ORTHO-CLINICAL DIAGNOSTICS, INC.
6901935
In Commercial Distribution

  • 10758750007448 ()
6901935

  • Anti-B red blood cell grouping IVD, antibody

MTS - 10758750005857

MTS Anti-B (Murine Monoclonal) Card
MICRO TYPING SYSTEMS, INC
MTS080015
In Commercial Distribution

  • 10758750005857 ()
MTS080015

  • Anti-B red blood cell grouping IVD, antibody

BIOCLONE - 10758750003075

ANTI-B (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
711320
In Commercial Distribution

  • 10758750003075 ()
711320

  • Anti-B red blood cell grouping IVD, antibody

VITROS - 10758750001149

VITROS Immunodiagnostic Products HBsAg Controls
ORTHO CLINICAL DIAGNOSTICS
6801390
In Commercial Distribution

  • 10758750001149 ()
  • 20758750001146 ()
6801390

  • Hepatitis B virus surface antigen IVD, control

LIAISON XL MUREX HBeAg - 08056771103404

No Description
DIASORIN SPA
318150
In Commercial Distribution

  • 18056771103401 ()
  • 08056771103404 ()


  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay

LIAISON XL MUREX Control HBsAg Qual - 08056771500210

No Description
DIASORIN S.P.A.
318251
In Commercial Distribution

  • 28056771500214 ()
  • 08056771500210 ()


  • Hepatitis B virus surface antigen IVD, control

ACCURUN® - 00816784020604

ACCURUN 325 Series 700 HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0098
In Commercial Distribution

  • 00816784020604 ()
2020-0098

  • Hepatitis B virus nucleic acid IVD, control

ACCURUN® - 00816784020598

ACCURUN 325 Series 200 HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0096
In Commercial Distribution

  • 00816784020598 ()
2020-0096

  • Hepatitis B virus nucleic acid IVD, control

ACCURUN® - 00816784020581

ACCURUN 325 Series 370 HBV DNA Positive Control 5 x 0.6 mL
Lgc Clinical Diagnostics, Inc.
2020-0095
In Commercial Distribution

  • 00816784020581 ()
2020-0095

  • Hepatitis B virus nucleic acid IVD, control

ACCURUN® - 00816784020352

ACCURUN 125 Anti-HBs 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0078
In Commercial Distribution

  • 00816784020352 ()
2015-0078

  • Hepatitis B virus surface antigen IVD, control

CalSet beta-Amyloid (1-42) II - 07613336166345

No Description
Roche Diagnostics GmbH
08821976190
In Commercial Distribution

  • 07613336166345 ()
08821976190

  • Amyloid B component IVD, calibrator

PreciControl HBsAg II Auto Confirm - 07613336183236

No Description
Roche Diagnostics GmbH
08741107162
In Commercial Distribution

  • 07613336183236 ()
08741107162

  • Hepatitis B virus surface antigen IVD, control

PreciControl HBsAg II - 07613336183168

No Description
Roche Diagnostics GmbH
04687876162
In Commercial Distribution

  • 07613336183168 ()
04687876162

  • Hepatitis B virus surface antigen IVD, control

PreciControl Release HBsAg II - 07613336182994

No Description
Roche Diagnostics GmbH
09366717190
In Commercial Distribution

  • 07613336182994 ()
09366717190

  • Hepatitis B virus surface antigen IVD, control

Exact Diagnostics - 00812242030703

HBV LOD
EXACT DIAGNOSTICS, LLC
HBVLOD
In Commercial Distribution

  • 00812242030703 ()
HBVLOD

  • Hepatitis B virus nucleic acid IVD, control

Exact Diagnostics - 00812242030130

HBV High Run Control
EXACT DIAGNOSTICS, LLC
HBVH102
In Commercial Distribution

  • 00812242030130 ()
HBVH102

  • Hepatitis B virus nucleic acid IVD, control

Exact Diagnostics - 00812242030123

HBV Low Run Control
EXACT DIAGNOSTICS, LLC
HBVL101
In Commercial Distribution

  • 00812242030123 ()
HBVL101

  • Hepatitis B virus nucleic acid IVD, control

Hepatitis B Virus Surface Antigen Control Slides - B502BSB9208CS0

Hepatitis B Virus Surface Antigen Control Slides
BIO SB, INC.
BSB-9208-CS
In Commercial Distribution

  • B502BSB9208CS0 ()
BSB-9208-CS

  • Hepatitis B virus surface antigen IVD, control

Hepatitis B Virus Core Antigen Control Slides - B502BSB9207CS0

Hepatitis B Virus Core Antigen Control Slides
BIO SB, INC.
BSB-9207-CS
In Commercial Distribution

  • B502BSB9207CS0 ()
BSB-9207-CS

  • Hepatitis B virus core antigen IVD, control

Hepatitis B Virus Surface Antigen control slides - B502BSB56230

Hepatitis B Virus Surface Antigen Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56230 ()
BSB 5623

  • Hepatitis B virus surface antigen IVD, control

Hepatitis B Virus Core Antigen control slides - B502BSB56160

Hepatitis B Virus Core Antigen Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56160 ()
BSB 5616

  • Hepatitis B virus core antigen IVD, control

Seraclone® Anti-B (ABO2) - 07611969950119

Blood Grouping Reagent Anti-B (ABO2); Seraclone® Murine Monoclonal (B005); for tube test; 10x10ml
Bio-Rad Medical Diagnostics GmbH
801350100
In Commercial Distribution

  • 07611969950119 ()
801350100

  • Anti-B red blood cell grouping IVD, antibody
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