THD Block US

GUDID 08033439419145

ASSUT EUROPE SPA

Barbed polyester suture, non-antimicrobial

• Primary Device ID: 08033439419145
• NIH Device Record Key: 212e8bc9-671a-46d0-a7ff-a92a2e4c7d31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THD Block US
• Version Model Number: 880086
• 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	08033439419145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150553

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

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: 2025-05-29
• Device Publish Date: 2025-05-21

Devices Manufactured by ASSUT EUROPE SPA

• 08033439419145 - THD Block US: 2025-05-29
• 08033439419145 - THD Block US: 2025-05-29
• 08033439416731 - FILBLOC: 2025-02-27
• 18033439002382 - ASSUFIL: 2024-08-19
• 18033439114085 - FILBLOC: 2024-08-19
• 18033439168712 - FILBLOC: 2024-08-19
• 18033439372812 - ASSUFIL: 2024-08-19
• 18033439374090 - FILBLOC: 2024-08-19
• 18033439374106 - FILBLOC: 2024-08-19