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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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NexStat Plus 3gm - 00858439001323

The hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. The hemostatic particles quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.
HEMOSTASIS, LLC
9430034
In Commercial Distribution

  • 00858439001408 ()
  • 00858439001323 ()

  • Weight: 3 Gram


  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

NexStat Plus 2gm - 00858439001262

The Hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. The hemostatic particles quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.
HEMOSTASIS, LLC
9430014
In Commercial Distribution

  • 00858439001293 ()
  • 00858439001262 ()

  • Weight: 2 Gram


  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

Lacrimedics - 00856611008016

No Description
Summit Medical, Inc.
1639
In Commercial Distribution

  • 00856611008016 ()


  • Lacrimal punctum plug

Lacrimedics - 00856611008009

No Description
Summit Medical, Inc.
1638
In Commercial Distribution

  • 00856611008009 ()


  • Lacrimal punctum plug

FCD-2 IMPLANT SYSTEM - 00857360007190

FCD-2 Implant System, ANCHOR
DECIMA SPINE, INC.
9063
In Commercial Distribution

  • 00857360007190 ()
9063-00

  • Trans-facet-screw internal spinal fixation system, sterile

FCD-2 IMPLANT SYSTEM - 00857360007176

FCD-2 Implant System, Stabilizer
DECIMA SPINE, INC.
9062
In Commercial Distribution

  • 00857360007176 ()
9062-00

  • Trans-facet-screw internal spinal fixation system, sterile

Tenex 2nd Generation Fuse Set - 00857356008859

No Description
TRICE MEDICAL, INC.
3-10-0529
In Commercial Distribution

  • 00857356008859 ()
3-10-0529

  • Hard/soft-tissue ultrasonic surgical system

Tenex 2nd Generation MicroTip, TXS, 2.0 WL - 00857356008781

No Description
TRICE MEDICAL, INC.
T600-020
In Commercial Distribution

  • 00857356008781 ()
  • 00857356008828 ()
T600-020

  • Hard/soft-tissue ultrasonic surgical system

Tenex 2nd Generation MicroTip, TXL, 3.0 WL - 00857356008767

No Description
TRICE MEDICAL, INC.
T600-030
In Commercial Distribution

  • 00857356008767 ()
  • 00857356008804 ()
T600-030

  • Hard/soft-tissue ultrasonic surgical system

PMMA - 00858174006003

PMMA (polymethyl methacrylate) hard contact lens for daily wear
LAGADO CORPORATION, THE
003
In Commercial Distribution

  • 00858174006003 ()


  • Hard corrective contact lens
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