ASSUFIL

GUDID 38033439003154

ASSUT EUROPE SPA

Polyester suture, bioabsorbable, multifilament, non-antimicrobial

• Primary Device ID: 38033439003154
• NIH Device Record Key: 3c4096c5-96b7-4ea1-a95c-ac2cafae0601
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSUFIL
• Version Model Number: FU395
• Company DUNS: 654747567
• Company Name: ASSUT EUROPE SPA
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	38033439003154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021767

FDA Product Code

• GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid

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: 2024-08-19
• Device Publish Date: 2024-08-09

On-Brand Devices [ASSUFIL]

• 38033439372847: FS414WAT
• 38033439372830: FW371WAP
• 38033439094459: FR479WAT
• 38033439043051: FR424AT
• 38033439003895: FV533
• 38033439003833: FW515
• 38033439003352: FR465
• 38033439003277: FS464
• 38033439003154: FU395
• 18033439372812: FQ469WBF
• 18033439002382: FR855