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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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3M™ Tegaderm™ Dressing Change IV Advanced Kit 25/Case 77-2100K01
3M COMPANY
77-2100K01
In Commercial Distribution

  • 50707387772425 ()
  • 30707387772421 ()
77-2100K01

  • Wearable percutaneous catheter/tube holder
  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
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
Waist/Leg Strap Extender
GOTOP MEDICAL INC
9029
In Commercial Distribution

  • 00854759007076 ()
9029

  • Penile tumescence long-term ambulatory recorder transducer
Leg Strap, reusable
GOTOP MEDICAL INC
9030
In Commercial Distribution

  • 00854759007069 ()
9030

  • Penile tumescence long-term ambulatory recorder transducer
Dis, Leg Strap, 12 Pk
GOTOP MEDICAL INC
61597
In Commercial Distribution

  • 00854759007052 ()
61597

  • Penile tumescence long-term ambulatory recorder transducer
Loop Covers, Dis, 12pk
GOTOP MEDICAL INC
9020
In Commercial Distribution

  • 00854759007045 ()
9020

  • Penile tumescence long-term ambulatory recorder transducer
Tip Tension Guide
GOTOP MEDICAL INC
9033
In Commercial Distribution

  • 00854759007038 ()
9033

  • Penile tumescence long-term ambulatory recorder transducer
Base Tension Guide
GOTOP MEDICAL INC
9021
In Commercial Distribution

  • 00854759007021 ()
9021

  • Penile tumescence long-term ambulatory recorder transducer
Awl, Cannulated
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039825290 ()
FA.IC.1001

  • Bone awl, reusable
Leg Strap, Disposable
GOTOP MEDICAL INC
31665
In Commercial Distribution

  • 10854759007059 ()
31665

  • Penile tumescence long-term ambulatory recorder transducer
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