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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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BD Leucocount™ - 00382903410019

Leucocount RBC Control Kit 25 Tests IVD
BECTON, DICKINSON AND COMPANY
341001
Not in Commercial Distribution

  • 00382903410019 ()
341001

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

BD Leucocount™ - 00382903405237

BD Leucocount™ Kit
BECTON, DICKINSON AND COMPANY
340523
Not in Commercial Distribution

  • 00382903405237 ()
340523

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

BD Multitest - 00382903405008

Multitest CD3/CD16+CD56/CD45/CD19 IVD
Becton, Dickinson And Company
340500
In Commercial Distribution

  • 00382903405008 ()
340500

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

BD Procount - 00382903404988

BD Procount™ Progenitor Cell Enumeration Kit
Becton, Dickinson And Company
340498
In Commercial Distribution

  • 00382903404988 ()
340498

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

BD Tritest - 00382903403837

Tritest CD3 FITC/CD4 PE/CD45 PerCP IVD
Becton, Dickinson And Company
340383
In Commercial Distribution

  • 00382903403837 ()
340383

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

BD Tritest - 00382903403448

Tritest CD3 FITC/CD8 PE/CD45 PerCP IVD
Becton, Dickinson And Company
340344
In Commercial Distribution

  • 00382903403448 ()
340344

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

BD Tritest - 00382903403004

BD Tritest™ CD3/CD16+CD56/CD45
Becton, Dickinson And Company
340300
In Commercial Distribution

  • 00382903403004 ()
340300

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

BD Tritest - 00382903402984

Tritest CD4 FITC/CD8 PE/CD3 PerCP IVD
Becton, Dickinson And Company
340298
In Commercial Distribution

  • 00382903402984 ()
340298

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

Simultest - 00382903401826

BD Simultest™ IMK-Lymphocyte
Becton, Dickinson And Company
340182
In Commercial Distribution

  • 00382903401826 ()
340182

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

FACSCount - 00382903401673

BD FACSCount Reagent Kit 50 Tests IVD
Becton, Dickinson And Company
340167
In Commercial Distribution

  • 00382903401673 ()
340167

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

AFFIRMAGEN - 10758750003914

0.8% Affirmagen® 3 (Pooled Cells)
ORTHO-CLINICAL DIAGNOSTICS, INC.
719211
In Commercial Distribution

  • 10758750003914 ()
719211

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

AFFIRMAGEN - 10758750003907

Affirmagen® (Pooled Cells)
ORTHO-CLINICAL DIAGNOSTICS, INC.
719210
In Commercial Distribution

  • 10758750003907 ()
719210

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

AFFIRMAGEN - 10758750003877

0.8% Affirmagen® (Pooled Cells)
ORTHO-CLINICAL DIAGNOSTICS, INC.
719201
In Commercial Distribution

  • 10758750003877 ()
719201

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

Enterovirus Panel Antigen Control Slide, 4 wells - B110QEP66040

No Description
Bion Enterprises, Ltd.
QEP-6604
In Commercial Distribution

  • B110QEP66040 ()
QEP-6604

  • Multiple enterovirus antigen IVD, control

Reverse-Cyte 3% (A1, A2, B) - 07640137340308

Reagent Red Blood Cells for confirmation of ABO Blood Grouping. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
3x10 ml
In Commercial Distribution

  • 07640137340308 ()
213632

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

Reverse-Cyte 3% (A1, B) - 07640137340292

Reagent Red Blood Cells for confirmation of ABO Blood Grouping. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
2x10 ml
In Commercial Distribution

  • 07640137340292 ()
213635

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

Reverse-Cyte 0.8% (A1, A2, B) - 07640137340322

Reagent Red Blood Cells for confirmation of ABO Blood Grouping in gel technique. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
3x10 ml
In Commercial Distribution

  • 07640137340322 ()
213662

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

Reverse-Cyte 0.8% (A1, B) - 07640137340315

Reagent Red Blood Cells for confirmation of ABO Blood Grouping in gel technique. For in vitro diagnotic use.
Medion Grifols Diagnostics AG
2x10 ml
In Commercial Distribution

  • 07640137340315 ()
213660

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

Biotestcell® A1 & B - 07611969952663

Reagent Red Blood Cells; Biotestcell® A1 & B; 3.0 - 3.4%; pooled cells for reverse grouping by the tube test; 2x10ml
Bio-Rad Medical Diagnostics GmbH
816057100
In Commercial Distribution

  • 07611969952663 ()
816057100

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

Erytypecell® A1 & B - 07611969952656

Reagent Red Blood Cells; 1.0 - 1.3%;pooled cells for reverse grouping with the TANGO instruments; 2x10ml
Bio-Rad Medical Diagnostics GmbH
816056100
In Commercial Distribution

  • 07611969952656 ()
816056100

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

IH-Cell A1 & B - 07611969952243

Reagent Red Blood Cells; 0.6 ± 0.1 %; Pooled cells for reverse grouping with IH-Cards; 2 x 10 mL
Bio-Rad Medical Diagnostics GmbH
814010100
In Commercial Distribution

  • 07611969952243 ()
814010100

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

Beckman Coulter® PK® Systems Reagent Red Blood Cells (A1 & B) - 33661562173182

Reagent Red Blood Cells A1 and B cells formulated for the use in Beckman Coulter® PK® Systems
DIAGAST
17318
In Commercial Distribution

  • 33661562173182 ()
17318

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

Procleix - 15420045504264

No Description
Hologic, Inc.
LBL BOX, DPROBE, ULTRIO, 200T, IVD
Not in Commercial Distribution

  • 15420045504264 ()
PRD-03709

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, reagent

Procleix - 15420045504257

No Description
Hologic, Inc.
LBL BOX, DPROBE, ULTRIO, 200T, IVD
Not in Commercial Distribution

  • 15420045504257 ()
PRD-03708

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, reagent

SMARTABLATE SCom. Recording-/CARTO® Cable - 04260166371352

SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 3 m
Stockert GmbH
M490021
In Commercial Distribution

  • 04260166371352 ()


  • Electrical-only medical device connection cable, reusable

SMARTABLATE-SCom. Recording-/CARTO® Cable - 04260166371345

SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 15 m
Stockert GmbH
M490023
In Commercial Distribution

  • 04260166371345 ()


  • Electrical-only medical device connection cable, reusable

OrthoFlex - 00190730002495

OrtFlx Com McLaughlin 022 LL4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-864
In Commercial Distribution

  • 00190730002495 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002488

OrtFlx Com McLaughlin 022 LR4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-863
In Commercial Distribution

  • 00190730002488 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002228

OrtFlx Com McLaughlin 022 UL2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-812
In Commercial Distribution

  • 00190730002228 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002204

OrtFlx Com McLaughlin 022 UR2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-811
In Commercial Distribution

  • 00190730002204 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002181

OrtFlx Com McLaughlin 022 UL1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-802
In Commercial Distribution

  • 00190730002181 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002167

OrtFlx Com McLaughlin 022 UR1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-801
In Commercial Distribution

  • 00190730002167 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002150

OrtFlx Com McLaughlin 018 LL5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-774
In Commercial Distribution

  • 00190730002150 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002143

OrtFlx Com McLaughlin 018 LR5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-773
In Commercial Distribution

  • 00190730002143 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002112

OrtFlx Com McLaughlin 018 LL4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-764
In Commercial Distribution

  • 00190730002112 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002105

OrtFlx Com McLaughlin 018 LR4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-763
In Commercial Distribution

  • 00190730002105 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002532

OrtFlx Com McLaughlin 022 LL5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-874
In Commercial Distribution

  • 00190730002532 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002525

OrtFlx Com McLaughlin 022 LR5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-873
In Commercial Distribution

  • 00190730002525 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001849

OrtFlx Com McLaughlin 018 UL2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-712
In Commercial Distribution

  • 00190730001849 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001825

OrtFlx Com McLaughlin 018 UR2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-711
In Commercial Distribution

  • 00190730001825 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001801

OrtFlx Com McLaughlin 018 UL1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-702
In Commercial Distribution

  • 00190730001801 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001788

OrtFlx Com McLaughlin 018 UR1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-701
In Commercial Distribution

  • 00190730001788 ()


  • Orthodontic bracket, plastic, single-use

Avalon - 00190730000651

Avalon Com McLaughlin 022 LL4 Rx -12° Tor. +2° Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A22-864
Not in Commercial Distribution

  • 00190730000651 ()


  • Orthodontic bracket, plastic, single-use

 B&B Monopolar Dissector - B089B653000

B&B E-P ELECTROSURGICAL DISSECTOR; ELECTRODE HANDLE ONLY, W/SUCTION-**Needs B68130 Monopolar Cable**
BLACK & BLACK SURGICAL, INC.
B65300
In Commercial Distribution

  • B089B653000 ()
B65300

  • Open-surgery electrosurgical electrode, monopolar, reusable

 B&B Monopolar Dissector - B089B652280

B&B E-P ELECTROSURGICAL DISSECTOR; 14 5''(36.5CM), STRAIGHT SHAFT, ANGLED TIP
BLACK & BLACK SURGICAL, INC.
B65228
In Commercial Distribution

  • B089B652280 ()
B65228

  • Open-surgery electrosurgical electrode, monopolar, reusable

 B&B Monopolar Dissector - B089B652270

B&B E-P ELECTROSURGICAL DISSECTOR; 14.5''(36.5CM), CURVED ON STRAIGHT, STRAIGHT TIP (1 PAIR)
BLACK & BLACK SURGICAL, INC.
B65227
In Commercial Distribution

  • B089B652270 ()
B65227

  • Open-surgery electrosurgical electrode, monopolar, reusable

Cleaner XT™ Rotational Thrombectomy System - 00886333222308

Cleaner XT™ Rotational Thrombectomy System 6F x 65cm
ARGON MEDICAL DEVICES, INC.
700009XT
In Commercial Distribution

  • 00886333222308 ()

  • 6F x 65cm
700009XT

  • Thrombectomy rotational catheter

Cleaner15™ Rotational Thrombectomy System - 00886333222339

Cleaner15™ Rotational Thrombectomy System 7F x 135cm
ARGON MEDICAL DEVICES, INC.
700115
In Commercial Distribution

  • 00886333222339 ()

  • 7F x 135cm
700115

  • Thrombectomy rotational catheter

Cleaner XT™ Rotational Thrombectomy System - 00886333222322

Cleaner XT™ Rotational Thrombectomy System 6F x 135cm
ARGON MEDICAL DEVICES, INC.
700109XT
In Commercial Distribution

  • 00886333222322 ()

  • 6F x 135cm
700109XT

  • Thrombectomy rotational catheter

Cleaner15™ Rotational Thrombectomy System - 00886333222315

Cleaner15™ Rotational Thrombectomy System 7F x 65cm
ARGON MEDICAL DEVICES, INC.
700015
In Commercial Distribution

  • 00886333222315 ()

  • 7F x 65cm
700015

  • Thrombectomy rotational catheter
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