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

  • 04260166371352 ()


  • Electrical-only medical device connection cable, reusable
SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 15 m
Stockert GmbH
M490023
In Commercial Distribution

  • 04260166371345 ()


  • Electrical-only medical device connection cable, reusable
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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 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 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
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 6F x 135cm
ARGON MEDICAL DEVICES, INC.
700109XT
In Commercial Distribution

  • 00886333222322 ()

  • 6F x 135cm
700109XT

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

  • 00886333222315 ()

  • 7F x 65cm
700015

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

  • 00886333222308 ()

  • 6F x 65cm
700009XT

  • Thrombectomy rotational catheter
No Description
REMEL EUROPE LIMITED
R30859001
In Commercial Distribution

  • 05056080501581 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30859602
In Commercial Distribution

  • 05056080500997 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30859203
In Commercial Distribution

  • 05056080500973 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30858701
In Commercial Distribution

  • 05056080501574 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30859502
In Commercial Distribution

  • 05056080500980 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30858801
In Commercial Distribution

  • 05056080500966 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Specimen Buffer Solution
BECTON, DICKINSON AND COMPANY
256391
Not in Commercial Distribution

  • 00382902563914 ()

  • Total Volume: 8 Milliliter
256391

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit
BECTON, DICKINSON AND COMPANY
255560
Not in Commercial Distribution

  • 00382902555605 ()
255560

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Group B Strep Test
BECTON, DICKINSON AND COMPANY
255460
Not in Commercial Distribution

  • 00382902554608 ()
255460

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Meningitis Combo Test Cards
BECTON, DICKINSON AND COMPANY
252480
Not in Commercial Distribution

  • 00382902524809 ()
252480

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
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