WoundClot Hemostatic Gauze

Basic Information

• Brand Name: WoundClot Hemostatic Gauze
• Primary DI: 07290016339307
• Version / Model: 3" X 39" OTC FDA
• Catalog Number: 101581901
• Company Name: CORE SCIENTIFIC CREATIONS LTD
• Labeler DUNS: 600041570
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-01
• Public Version: 2
• Public Version Date: 2023-08-15
• Public Version Status: Update
• Public Device Record Key: 0b88aed4-9396-4b5a-b468-e76927d88ab6

Device Description

WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
38771	Plant polysaccharide haemostatic agent, bioabsorbable	A bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it is not dedicated to bone haemostasis. It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. It may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290016339304	GS1	BOX	10	In Commercial Distribution
Primary	07290016339307	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K160679	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 95 Degrees Fahrenheit