NexStat 9130144

• FDA 510(k) K102459 decided 3 Dec 2010 Active
• FDA GUDID UDI-DI 00858439001439 listed 30 Sep 2020 Listed

1. 3 Dec 2010 Cleared FDA 510(k) K102459
2. 30 Sep 2020 Listed FDA GUDID 00858439001439

Trade name

NexStat

Generic name

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

Model / reference

9130144

Primary DI / UDI-DI

00858439001439

510(k) Number

K102459 ↗

FDA product code

FRO

GMDN term

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

Device class

U

GUDID distribution status

In Commercial Distribution

Size

Weight — 3 Gram

Category: Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

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• DUODERM HYDROACTIVE GRANULES by Convatec, A Division of E.R. Squibb & Sons
• IPM WOUND GEL BIO by Glycobiosciences, Inc.
• EX-111 WOUND DRESSING by Variseal Manufacturing Corp.
• VASHE WOUND THERAPY SOLUTION by Puricore, Inc.
• Antibacterial Bandage by Jiangsu Excellence Medical Supplies Co., Ltd.
• SURESKIN STANDARD, BORDER, AND THIN by Euromed A/S

• BleedArrest ER 9110264

  Unclassified

  FDA 510(k) K102459 Active Cleared 3 Dec 2010 GUDID on market

• PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint 9210584

  Class I

  FDA 510(k) ×2 Active Cleared 25 Jul 2012 GUDID on market

• NexPak 9110524

  Class I

  GUDID on market

• BoneSeal 2.5 gram Ingot 9550054

  Unclassified

  FDA 510(k) K142348 Active Cleared 23 Jan 2015 GUDID on market

See all devices from Hemostasis, LLC →