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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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Easy@Home Pregnancy Test (20 HCG strips) - 00850253007697

20 tests kit; HCG strips
EASY HEALTHCARE CORPORATION
EZW1-S
In Commercial Distribution

  • 10850253007694 ()
  • 00850253007697 ()
  • 30850253007698 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

VASER - 00850608002612

CANISTER, 1250CC, CASE 20, VENTX
SOLTA MEDICAL
130-0168
In Commercial Distribution

  • 00850608002612 ()
130-0168

  • Liposuction system

X-Series, X8 - 00851113007161

Dual Lead Cable 20" Kit
ADVANCED BRAIN MONITORING, INC.
UN03-4004
In Commercial Distribution

  • 00851113007161 ()


  • Analytical non-scalp cutaneous lead
  • Electrocardiographic lead set, reusable

OtoClear® Aquabot® Kit - 00859911004887

OtoClear Powered by Aquabot, 20
Bionix, LLC
7270
In Commercial Distribution

  • 00859911004887 ()
7270

  • Ear canal irrigation kit, reusable

MORRISON MEDICAL - 00647921158825

CDBD.SPLNT.34" 3 PC.FOAM/20
MORRISON MEDICAL, LTD
1588-20
In Commercial Distribution

  • 00647921158825 ()
  • 00647921158832 ()
1588-20

  • First aid limb splint, non-mouldable, single-use

Elite - 00643293026762

Elite Trendelenburg System 20 Degrees
TRULIFE LIMITED
ELTS20
In Commercial Distribution

  • 00643293026762 ()


  • Operating table patient pressure distribution pad, reusable

MORRISON MEDICAL - 00647921257825

COR.PLSTC.SPLNT 3 PC.FM.34"/20
MORRISON MEDICAL, LTD
2578-20
In Commercial Distribution

  • 00647921257825 ()
  • 00647921257832 ()
2578-20

  • First aid limb splint, non-mouldable, single-use

TrinityBiotech - 05391516746342

Uni-Gold™ Cryptosporidium, 20 Tests
MARDX DIAGNOSTICS, INC.
1206620
In Commercial Distribution

  • 05391516746342 ()
1206620

  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot

Trinity Biotech - 05391516746328

Uni-Gold™ Giardia, 20 Tests
MARDX DIAGNOSTICS, INC.
1206610
In Commercial Distribution

  • 05391516746328 ()
1206610

  • Giardia lamblia immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516741552

Glucose-6-Phosphate Dehyrodgenase (G-6-PDH) (20 Tests)
TRINITY BIOTECH PUBLIC LIMITED COMPANY
345-A
In Commercial Distribution

  • 05391516741552 ()

  • 20 Tests
345-A

  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry
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