PuraStat

Basic Information

• Brand Name: PuraStat
• Primary DI: 03664883000044
• Version / Model: 621-043
• Catalog Number: 621-061
• Company Name: 3-D MATRIX EUROPE
• Labeler DUNS: 264081545
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-01
• Public Version: 1
• Public Version Date: 2026-02-09
• Public Version Status: New
• Public Device Record Key: ee3facf2-4f8c-4c45-ad60-99e879c3f8b5

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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
QAU	Hemostatic Device For Endoscopic Gastrointestinal Use	General, Plastic Surgery	878.4456	2
PHN	Protective Coating, Mucoadhesive Application, For The Rectal Mucosa	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
60919	Synthetic peptide haemostatic agent	A sterile, bioabsorbable device containing synthetic peptides intended to be applied to a surgical site to rapidly facilitate local haemostasis primarily through formation of a peptide hydrogel; it does not contain an antimicrobial agent. It is typically available as an aqueous solution (e.g., prefilled syringe) that can be applied directly to the wound where it remains to be absorbed by the body. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03664883000044	GS1