WoundSeal®

Basic Information

• Brand Name: WoundSeal®
• Primary DI: 00834061000019
• Version / Model: WSO001
• Catalog Number: WSO001
• Company Name: BIOLIFE, L.L.C.
• Labeler DUNS: 135872476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-28
• Public Version: 4
• Public Version Date: 2024-01-18
• Public Version Status: Update
• Public Device Record Key: bf33e5a3-0e2e-4097-8031-982c3d13d4bf

Device Description

WoundSeal® Rapid Response

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
47917	Non-organic haemostatic agent	A non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it might additionally be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable manual or electronic devices for application may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00834061006318	GS1	Case	24	In Commercial Distribution
Primary	00834061000019	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070520	000
K080210	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a clean, dry place