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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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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 - 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 - 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

 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

Wellcogen S pneumoniae - 05056080501581

No Description
REMEL EUROPE LIMITED
R30859001
In Commercial Distribution

  • 05056080501581 ()


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

Wellcogen Strep B - 05056080501574

No Description
REMEL EUROPE LIMITED
R30858701
In Commercial Distribution

  • 05056080501574 ()


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

NA - 05056080500997

No Description
REMEL EUROPE LIMITED
R30859602
In Commercial Distribution

  • 05056080500997 ()


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

NA - 05056080500980

No Description
REMEL EUROPE LIMITED
R30859502
In Commercial Distribution

  • 05056080500980 ()


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

NA - 05056080500973

No Description
REMEL EUROPE LIMITED
R30859203
In Commercial Distribution

  • 05056080500973 ()


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

NA - 05056080500966

No Description
REMEL EUROPE LIMITED
R30858801
In Commercial Distribution

  • 05056080500966 ()


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

BD Directigen™ Specimen Buffer Solution - 00382902563914

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 - 00382902555605

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 - 00382902554608

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 - 00382902524809

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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