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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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LIFECODES LSA Class I is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation.
IMMUCOR GTI DIAGNOSTICS, INC.
265100IVD
In Commercial Distribution

  • 10888234400332 ()
265100IVD

  • HLA class I antigen tissue typing IVD, kit, multiplex
Bulk Gauze Sponges , 3"X3", 12 Ply,XRay Detectable, Steam Pretreated, Bleached White, Banded In 10'S, 200 Pc(s)/Bag, 4000 Pc(s)/Case
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534830051 ()
  • 00683534830055 ()
GS-3312-6S

  • Radiopaque woven surgical sponge
WoundClot hemostatic gauz, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required, including traumatic bleeding.
CORE SCIENTIFIC CREATIONS LTD
3"X8" EMS FDA
In Commercial Distribution

  • 17290016339144 ()
  • 07290016339147 ()
101482901

  • Plant polysaccharide haemostatic agent, bioabsorbable
PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of less than or equal to 1000. The device is sterile and packaged in a vial sealed in a single pouch.
ORGANOGENESIS INC.
515-063
In Commercial Distribution

  • 00618474000411 ()

  • Weight: 1000 Milligram


  • Collagen wound matrix dressing
PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of less than or equal to 1000. The device is sterile and packaged in a vial sealed in a single pouch.
ORGANOGENESIS INC.
515-061
In Commercial Distribution

  • 00618474000404 ()

  • Weight: 500 Milligram


  • Collagen wound matrix dressing
PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of less than or equal to 1000. The device is sterile and packaged in a vial sealed in a single pouch.
ORGANOGENESIS INC.
515-059
In Commercial Distribution

  • 00618474000398 ()

  • Weight: 100 Milligram


  • Collagen wound matrix dressing
Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque strip and coated in chitosan-based hemostatic granules. The device is intended to control bleeding by forming a gel-like plug at the site of bleeding.The device may be left in place for up to 72 hours.
MEDTRADE PRODUCTS LIMITED
FG08839291
In Commercial Distribution

  • 35060206631589 ()
  • 15060206631585 ()
  • 75060206631587 ()

  • Width: 3 Inch
  • Length: 5 Feet
  • 3inch x 5ft z-fold gauze
FG08839291

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The ARK Methotrexate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5026-0001-00
In Commercial Distribution

  • 00858724003056 ()
5026-0001-00

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required, including traumatic bleeding.
CORE SCIENTIFIC CREATIONS LTD
8"X12" FDA
In Commercial Distribution

  • 17290016339533 ()
  • 07290016339536 ()
101023901

  • Plant polysaccharide haemostatic agent, bioabsorbable
WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required, including traumatic bleeding.
CORE SCIENTIFIC CREATIONS LTD
3"X39" FDA
In Commercial Distribution

  • 17290016339526 ()
  • 07290016339529 ()
101081901

  • Plant polysaccharide haemostatic agent, bioabsorbable
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