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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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WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
CORE SCIENTIFIC CREATIONS LTD
2"X2" OTC FDA
In Commercial Distribution

  • 17290016339397 ()
  • 07290016339390 ()
101555901

  • Plant polysaccharide haemostatic agent, bioabsorbable
WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
CORE SCIENTIFIC CREATIONS LTD
8"X12" OTC FDA
In Commercial Distribution

  • 17290016339380 ()
  • 07290016339383 ()
101523901

  • Plant polysaccharide haemostatic agent, bioabsorbable
WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
CORE SCIENTIFIC CREATIONS LTD
4"X4" OTC FDA
In Commercial Distribution

  • 07290016339376 ()
  • 17290016339373 ()
101511901

  • Plant polysaccharide haemostatic agent, bioabsorbable
WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
CORE SCIENTIFIC CREATIONS LTD
3" X 39" OTC FDA
Not in Commercial Distribution

  • 17290016339304 ()
  • 07290016339307 ()
101581901

  • Plant polysaccharide haemostatic agent, bioabsorbable
Hemostatic Gauze. The device is indicated for: Temporary external treatment to control moderate to severe bleeding Temporary topical dressing for bleeding control associated with minor wounds including control of minor external bleeding and exudate from sutures and/or surgical procedures. Hemostatic gauze is for temporary external use only
MEDTRADE PRODUCTS LIMITED
FG07734331
In Commercial Distribution

  • 75060206630597 ()
  • 35060206630599 ()
  • 15060206630595 ()

  • Width: 17 Millimeter
  • Length: 120 Millimeter
  • Supplied folded size 17mm by 60mm
FG07734331

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Hemostatic Gauze: The device is indicated for: Temporary external treatment for controlling moderate to severe bleeding. Temporary topical dressing for bleeding control associated with minor wounds including control of minor external bleeding and exudate from sutures and/or surgical procedures. Hemostatic gauze is for temporary external use only.
MEDTRADE PRODUCTS LIMITED
FG04534191
In Commercial Distribution

  • 35060206630629 ()
  • 15060206630625 ()
  • 75060206630627 ()

  • Supplied folded size 2in by 2in
  • Full dressing size 4in by 4in (10.2cm by 10.2cm)
  • Length: 4 Inch
  • Width: 4 Inch
FG04534191

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Each Vascular Solutions D-Stat® flowable hemostat (D-Stat) includes the following components: Thrombin vial (5,000 units); Collagen (200mg), contained in 10ml syringe with attached mixing luer; Diluent vial (5ml); Mixing accessories (10ml syringe and needleless, non-coring vial access device); Applicator tips: (1) small bore tip, (1) 20-Gauge, 2.75" needle. The thrombin is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine-origin in the presence of calcium chloride. It is supplied as a sterile powder that has been freeze-dried in the final container. Also contained in the thrombin vial are mannitol and sodium chloride. Mannitol is included to make the dried product friable and more readily soluble. The material contains no preservative and has been chromatographically purified. Thrombin requires no intermediate physiological agent for its reaction. It converts fibrinogen directly to fibrin. The collagen is a soft, white, pliable, absorbent hemostatic agent derived from purified bovine deep flexor tendon. It is prepared in a loose fibrous form. Collagen attracts platelets that adhere to the fibrils and undergo the release phenomenon to trigger aggregation of platelets into thrombi in the interstices of the fibrous mass. The collagen provides a three-dimensional matrix for additional strengthening of the clot. The effect on platelet adhesion and aggregation is not inhibited by heparin in vitro. The diluent is a sterile solution of calcium chloride and water, buffered with tromethamine (TRIS). Using the mixing accessories, both the thrombin and collagen are reconstituted with the diluent prior to use. The hemostat is delivered to the intended treatment site using the provided applicator tips. Hemostasis is achieved by the physiological coagulation-inducing properties of the D-Stat. The D-Stat is biocompatible, non-pyrogenic, and intended to be left in situ.
Vascular Solutions, Inc.
4000
In Commercial Distribution

  • M20640000 ()
  • M20640001 ()


  • Collagen haemostatic agent, non-antimicrobial
Pulmonary Valve and Conduit SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue.
Artivion, Inc.
SGPV00
In Commercial Distribution

  • 00877234000447 ()

  • Internal Diameter: Ranges from 6mm to 32mm (allograft specific)
SGPV00

  • Cadaveric heart valve prosthesis, decellularized, non-sterile
LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens.
IMMUCOR GTI DIAGNOSTICS, INC.
QS12G
Not in Commercial Distribution

  • 10888234500094 ()
QS12G

  • HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)
ARK™ Methotrexate II Dilution Buffer is intended for dilution of specimens containing high concentrations of methotrexate for the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0004-00
In Commercial Distribution

  • 00812101031223 ()
5071-0004-00

  • Methotrexate therapeutic drug monitoring IVD, calibrator
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