NexStat Plus 3gm

GUDID 00858439001408

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

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

• Primary Device ID: 00858439001408
• NIH Device Record Key: 728140bb-2a81-455e-9d01-8d82c364c12c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexStat Plus 3gm
• Version Model Number: 9430034
• Company DUNS: 801380697
• Company Name: HEMOSTASIS, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com

Device Dimensions

• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858439001323 [Primary]
GS1	00858439001408 [Package]; Contains: 00858439001323; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122886

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-08
• Device Publish Date: 2020-09-30

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• 00858439001293 - NexStat Plus 2gm: 2020-10-08 The Hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide
• 00858439001408 - NexStat Plus 3gm: 2020-10-08The 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.
• 00858439001408 - NexStat Plus 3gm: 2020-10-08 The hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide
• 00858439001439 - NexStat: 2020-10-08 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th