StatSeal®

Basic Information

• Brand Name: StatSeal®
• Primary DI: 00834061000163
• Version / Model: DL016
• Catalog Number: DL016
• 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: c1bb91dc-c858-4926-9cf2-aa87801eb30f

Device Description

StatSeal® Disc - Large

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
Primary	00834061000163	GS1
Package	00834061006165	GS1	Inner Carton	6	In Commercial Distribution
Package	00834061006264	GS1	Case	4	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130324	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.4	Centimeter
Device Size Text, specify			~10-14 Fr

Storage Conditions

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