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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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REMEL - 00848838004063

CDC Blood/B Frag (BBE) Biplate 100/PK
REMEL, INC.
R02176
In Commercial Distribution

  • 00848838004063 ()
R02176

  • Differential/selective agar culture medium IVD

REMEL - 00848838003592

Anaer Reduc LKV/B Frag (BBE) Biplate 10/
REMEL, INC.
R02006
In Commercial Distribution

  • 00848838003592 ()
R02006

  • Differential/selective agar culture medium IVD

810nm 200mW Acu Tip PRX100 B/G - 05060494130398

S2093 810nm 200mW Acu Tip PRX100 B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130398 ()


  • Red-light phototherapy unit, professional

NA - 00643169783348

CUSTOM PACK TL9H74R1 4PK XP8 1 W/B
MEDTRONIC, INC.
TL9H74R1
Not in Commercial Distribution

  • 20643169783359 ()
  • 00643169783348 ()


  • Cardiopulmonary bypass system blood tubing set

na - 00643169785588

DISTRACTOR 6550008 5.5/6.0 SV COMP/DST B
MEDTRONIC SOFAMOR DANEK, INC.
6550008
In Commercial Distribution

  • 00643169785588 ()


  • Orthopaedic fixation implant alignment tool

NA - 00643169855175

CUSTOM PACK CB9L24R 5PK L I M B
MEDTRONIC, INC.
CB9L24R
In Commercial Distribution

  • 20643169855186 ()
  • 00643169855175 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00643169838857

CUSTOM PACK TL9H74R2 4PK XP8 1 W/B
MEDTRONIC, INC.
TL9H74R2
Not in Commercial Distribution

  • 20643169838868 ()
  • 00643169838857 ()


  • Cardiopulmonary bypass system blood tubing set

Trinity Biotech - 05391516746281

B. burgdorferi EIA (IgM) Test System (480 Tests)
MARDX DIAGNOSTICS, INC.
40-8696M/J
In Commercial Distribution

  • 05391516746281 ()
40-8696M/J

  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516746274

B. burgdorferi EIA (IgM) Test System (96 Tests)
MARDX DIAGNOSTICS, INC.
40-8696M
In Commercial Distribution

  • 05391516746274 ()
40-8696M

  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516746267

B. burgdorferi EIA (IgG) Test System (96 Tests)
MARDX DIAGNOSTICS, INC.
40-8696G
In Commercial Distribution

  • 05391516746267 ()
40-8696G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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