PuraStat 621-061

GUDID 03664883000044

3-D MATRIX EUROPE

Synthetic peptide haemostatic agent

• Primary Device ID: 03664883000044
• NIH Device Record Key: ee3facf2-4f8c-4c45-ad60-99e879c3f8b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PuraStat
• Version Model Number: 621-043
• Catalog Number: 621-061
• Company DUNS: 264081545
• Company Name: 3-D MATRIX EUROPE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03664883000044 [Primary]

FDA Product Code

• QAU: Hemostatic Device For Endoscopic Gastrointestinal Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-09
• Device Publish Date: 2026-02-01

On-Brand Devices [PuraStat]

• 04560436590354: 621-035
• 03664883000044: 621-043