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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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K-ASSAY® Fibrinogen Reagent (L) - 00816426020351

For the quantitative determination of human fibrinogen in plasma.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-088
Not in Commercial Distribution

  • 00816426020351 ()
KAI-088

  • Fibrinogen assay (factor I) IVD, reagent

EasyTouch - MHC18252312

ET 25G 1 in 3mL Fluringe (FlipLock Exch Needle)
MHC MEDICAL PRODUCTS, LLC
825231
In Commercial Distribution

  • MHC18252311 ()
  • MHC18252312 ()


  • Insulin syringe/needle, basic

EasyTouch - MHC18225112

ET 25G 1 in 1mL Fluringe (FlipLock Exch Needle)
MHC MEDICAL PRODUCTS, LLC
822511
In Commercial Distribution

  • MHC18225111 ()
  • MHC18225112 ()


  • Insulin syringe/needle, basic

EasyTouch - MHC18152002

ET 25G 5/8 in Fluringe (FlipLock Needle Only)
MHC MEDICAL PRODUCTS, LLC
815200
In Commercial Distribution

  • MHC18152001 ()
  • MHC18152002 ()


  • Hypodermic needle, single-use

NA - 00817573023370

LIGHT BOND MED PASTE IN TIPS W/FLUORIDE (5g)
LANCER ORTHODONTICS, INC.
811-104
In Commercial Distribution

  • 00817573023370 ()


  • Fatty acid dental cement

Curaplex - 00815277021210

Curaplex Automated External Defibrillator (AED) Kit in Yellow Pouch
BOUND TREE MEDICAL, LLC
651777
In Commercial Distribution

  • 00815277021210 ()
  • 00810071639272 ()
651777

  • Nitrile examination/treatment glove, non-powdered, antimicrobial
  • Safety razor, single-use
  • Antiseptic skin towelette
  • Cardiopulmonary resuscitation mask, single-use
  • Dry medical towel/wipe, single-use
  • Bandage scissors, reusable
  • Laboratory waste receptacle IVD

NA - 00815634020290

CANNULA TIP, DUAL CANNULA 5 MM X 12.5 IN
Micromedics, Inc.
AMS612
In Commercial Distribution

  • 20815634020294 ()
  • 10815634020297 ()
  • 00815634020290 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

Curaplex - 00815277021975

Curaplex AED Support Kit w/ CPR Microshield in Pouch
BOUND TREE MEDICAL, LLC
681231
In Commercial Distribution

  • 00815277021975 ()


  • Face splash shield, single-use
  • Safety razor, single-use
  • Nitrile examination/treatment glove, non-powdered, antimicrobial
  • General-purpose surgical scissors, single-use
  • Orthopaedic fixation plate, bioabsorbable
  • Laboratory waste receptacle IVD
  • Cardiopulmonary resuscitation mask, single-use
  • Skin cleaning wipe

Curaplex - 00815277021968

Curaplex AED Support Kit w/ CPR Microshield in Polybag
BOUND TREE MEDICAL, LLC
681229
In Commercial Distribution

  • 00815277021968 ()


  • Face splash shield, single-use
  • Laboratory waste receptacle IVD
  • Cardiopulmonary resuscitation mask, single-use
  • General-purpose surgical scissors, single-use
  • Nitrile examination/treatment glove, non-powdered, antimicrobial
  • Safety razor, single-use
  • Orthopaedic fixation plate, bioabsorbable
  • Skin cleaning wipe

OPTICS ONE - 00815384020397

Leica Bonnet Cover 20 in Dia w/68mm Lens
MEDICAL TECHNIQUE, INC.
4708-40
In Commercial Distribution

  • 00815384020410 ()
  • 00815384020403 ()
  • 00815384020397 ()
4708-40

  • Instrument/equipment drape, single-use, sterile
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