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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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VasoPrep Vein Preparation Kit - 00860002037813

VasoPrep Vein Preparation Kit
VASOPREP SURGICAL, LLC
VAP-VSR-0002
In Commercial Distribution

  • 00860002037813 ()


  • Vein irrigation/distention set

EasiSlush - 00860001991208

EasiSlush (Sodium Chloride Solution for Sterile Slush Preparation) is 1.25L sterile 0.9% Sodium Chloride Solution in a 2L bag. It is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport.
Bridge To Life Ltd.
BTLE-1250
In Commercial Distribution

  • 00860001991208 ()
  • 10860001991205 ()


  • Inhalation therapy saline solution, isotonic

Onset - 00860001977349

Sodium Bicarbonate 4 Pack
Onpharma Company
555-01
In Commercial Distribution

  • 00860001977349 ()


  • Fluid transfer set, general-purpose

Onset - 00860001977301

Onset Cartridge Connector
Onpharma Company
40045
Not in Commercial Distribution

  • 00860001977301 ()


  • Fluid transfer set, general-purpose

Latter-Day Armor Adhesive Bandages - 00860001904314

Decorated Adhesive Bandages, assorted sizes, strips 0.75 IN x 3 IN (19 mm x 76 mm); circles 1.25 IN x 1.25 IN (31 mm x 31 mm)
Aso LLC
860001904314
Not in Commercial Distribution

  • 20860001904318 ()
  • 00860001904314 ()
  • 60860001904316 ()


  • Skin-cover adhesive strip, non-antimicrobial

P.S. - 00860001852400

This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180 mm, nominal width 52 mm, and nominal thickness 0.045mm. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and IS0 407. The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted infections.
ISSAWRAP INC
Exceptionally Thin Latex Condoms
In Commercial Distribution

  • 00860001852400 ()
  • 00860001852417 ()


  • Basic male condom, Hevea-latex

PuraGel 5mL - 00860001820898

PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (5 ml)
3-D MATRIX INC.
651-006
In Commercial Distribution

  • 00860001820898 ()
651-006

  • Synthetic peptide haemostatic agent

PuraStat (3mL) - 00860001820874

PuraStat is a hemostat for mild and moderate bleeding intended to be used in gastrointestinal surgery (3 mL)
3-D MATRIX INC.
621-062
In Commercial Distribution

  • 00860001820874 ()
621-062

  • Non-organic haemostatic agent

PuraStat (1mL) - 00860001820867

PuraStat Gel is a hemostat for mild and moderate bleeding intended to be used in gastrointestinal surgery (1 mL).
3-D MATRIX INC.
621-061
In Commercial Distribution

  • 00860001820867 ()
621-061

  • Non-organic haemostatic agent

PuraSinus 1mL - 00860001820843

PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (1 mL)
3-D MATRIX INC.
651-007
In Commercial Distribution

  • 00860001820843 ()
651-007

  • Intranasal splint, biodegradable
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