AccessGUDID - DEVICE: NexStat (00858439001439)

GUDID

Device Identifier (DI) Information

Brand Name: NexStat
Version or Model: 9130144
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEMOSTASIS, LLC

Primary DI Number: 00858439001439
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801380697 *Terms of Use

Device Description: The Hemostasis NexStat 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58059	Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial	A non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102459	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Weight: 3 Gram

Device Record Status

Public Device Record Key: 06445fcc-2c58-4ce7-8137-067f715df05c
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 2020