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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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exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium carboxymethylcellulose (CMC), cellulose fibers, and silver (0.2mg Ag/cm2) (1.7wt/wt%). The silver in the dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing, as shown in vitro, for up to seven (7) days against Gram-positive and Gram-negative bacteria. exsalt™ CMC Gelling Fiber Dressing absorbs high amounts of wound fluid and creates a soft cohesive gel that intimately conforms to the wound surface and maintains a moist wound healing environment.
Exciton Technologies Inc
PN-09-0122
In Commercial Distribution

  • 07540127000208 ()
  • 07540127000192 ()
  • 07540127000215 ()

  • 4" x 5"
GF0405

  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium carboxymethylcellulose (CMC), cellulose fibers, and silver (0.2mg Ag/cm2) (1.7wt/wt%). The silver in the dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing, as shown in vitro, for up to seven (7) days against Gram-positive and Gram-negative bacteria. exsalt™ CMC Gelling Fiber Dressing absorbs high amounts of wound fluid and creates a soft cohesive gel that intimately conforms to the wound surface and maintains a moist wound healing environment.
Exciton Technologies Inc
PN-09-0121
In Commercial Distribution

  • 07540127000178 ()
  • 07540127000161 ()
  • 07540127000185 ()

  • 2" x 2"
GF0202

  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
The ARK™ Methotrexate II 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
5071-0001-01
In Commercial Distribution

  • 00812101031179 ()
5071-0001-01

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
The ARK™ Methotrexate II 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
5071-0001-00
In Commercial Distribution

  • 00812101031162 ()
5071-0001-00

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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
SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of superficial dermal wounds, split-skin graft donor sites, pressure and venous ulcers, and 2nd degree burns. The biodegradable matrix is designed for trauma and surgical wounds involving soft tissues. The SupraSDRM matrix is available in various sizes for use in covering and protecting superficial and partial thickness soft tissue wounds.
Polymedics Innovations GmbH
SupraSDRM 18x18
In Commercial Distribution

  • 04260184023424 ()
  • 04260184023431 ()
311818-US

  • Synthetic wound matrix dressing
SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of superficial dermal wounds, split-skin graft donor sites, pressure and venous ulcers, and 2nd degree burns. The biodegradable matrix is designed for trauma and surgical wounds involving soft tissues. The SupraSDRM matrix is available in various sizes for use in covering and protecting superficial and partial thickness soft tissue wounds.
Polymedics Innovations GmbH
SupraSDRM 18x9
In Commercial Distribution

  • 04260184023325 ()
  • 04260184023332 ()
311809-US

  • Synthetic wound matrix dressing
SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of superficial dermal wounds, split-skin graft donor sites, pressure and venous ulcers, and 2nd degree burns. The biodegradable matrix is designed for trauma and surgical wounds involving soft tissues. The SupraSDRM matrix is available in various sizes for use in covering and protecting superficial and partial thickness soft tissue wounds.
Polymedics Innovations GmbH
SupraSDRM 9x9
In Commercial Distribution

  • 04260184023226 ()
  • 04260184023233 ()
310909-US

  • Synthetic wound matrix dressing
SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of superficial dermal wounds, split-skin graft donor sites, pressure and venous ulcers, and 2nd degree burns. The biodegradable matrix is designed for trauma and surgical wounds involving soft tissues. The SupraSDRM matrix is available in various sizes for use in covering and protecting superficial and partial thickness soft tissue wounds.
Polymedics Innovations GmbH
SupraSDRM Disk24
In Commercial Distribution

  • 04260184023158 ()
  • 04260184023141 ()
31D024-US

  • Synthetic wound matrix dressing
SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of superficial dermal wounds, split-skin graft donor sites, pressure and venous ulcers, and 2nd degree burns. The biodegradable matrix is designed for trauma and surgical wounds involving soft tissues. The SupraSDRM matrix is available in various sizes for use in covering and protecting superficial and partial thickness soft tissue wounds.
Polymedics Innovations GmbH
SupraSDRM Disk18
In Commercial Distribution

  • 04260184023134 ()
  • 04260184023127 ()
31D018-US

  • Synthetic wound matrix dressing
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