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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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
Size: 3.2 cm; Type: Clear
Boston Medical Products, Inc.
60-101
In Commercial Distribution

  • EBES601010 ()
  • EBES601011 ()

  • Outer Diameter: 32 Millimeter
60-101

  • Nasal septal button
21 gauge Winged Needle Infusion Set
SPECIALTY SURGICAL PRODUCTS INC
WNIS01
Not in Commercial Distribution

  • M746WNIS011 ()
  • M746WNIS010 ()
WNIS01

  • Skin-port tissue expander
Softspan™ Tissue Expander, Bauer Design Remote Injection Port, Smooth Surface, Reinforced Base
SPECIALTY SURGICAL PRODUCTS INC
BTE070
Not in Commercial Distribution

  • M746BTE0700 ()

  • Width: 6 Centimeter
BTE070

  • Skin-port tissue expander
AlloX Remote Port Tissue Expander Accessories, For Use with SSP AlloX Remote Drain Port Tissue Expanders
SPECIALTY SURGICAL PRODUCTS INC
ARPA01
Not in Commercial Distribution

  • M746ARPA010 ()
ARPA01

  • Skin-port tissue expander
AlloX Tissue Expander Low Pole Plus-Full Height Profile, Smooth Surface, w/ Suture Tabs
SPECIALTY SURGICAL PRODUCTS INC
AlloX-FH16SE
Not in Commercial Distribution

  • M746ALLOXFH16SE0 ()

  • Width: 16.0 Centimeter
AlloX-FH16SE

  • Skin-port tissue expander
AlloX Tissue Expander Low Pole Plus-Full Height Profile, Smooth Surface
SPECIALTY SURGICAL PRODUCTS INC
AlloX-FH16S
Not in Commercial Distribution

  • M746ALLOXFH16S0 ()

  • Width: 16.0 Centimeter
AlloX-FH16S

  • Skin-port tissue expander
AlloX Tissue Expander Low Pole Plus-Full Height Profile, Textured Surface, w/ Suture Tabs
SPECIALTY SURGICAL PRODUCTS INC
AlloX-FH16E
Not in Commercial Distribution

  • M746ALLOXFH16E0 ()

  • Width: 16.0 Centimeter
AlloX-FH16E

  • Skin-port tissue expander
AlloX Tissue Expander Low Pole Plus-Full Height Profile, Textured Surface
SPECIALTY SURGICAL PRODUCTS INC
AlloX-FH16
Not in Commercial Distribution

  • M746ALLOXFH160 ()

  • Width: 16.0 Centimeter
AlloX-FH16

  • Skin-port tissue expander
AlloX Tissue Expander Low Pole Plus-Full Height Profile, Smooth Surface, w/ Suture Tabs
SPECIALTY SURGICAL PRODUCTS INC
AlloX-FH15SE
Not in Commercial Distribution

  • M746ALLOXFH15SE0 ()

  • Width: 15.0 Centimeter
AlloX-FH15SE

  • Skin-port tissue expander
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