TBS PTFE Suture

GUDID 08800039006675

PURGO BIOLOGICS Inc.

Polyolefin/fluoropolymer suture, monofilament

• Primary Device ID: 08800039006675
• NIH Device Record Key: 0bc7b3ae-9fbe-4162-9b9b-9ec202b727c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TBS PTFE Suture
• Version Model Number: PTFE5022
• Company DUNS: 687429456
• Company Name: PURGO BIOLOGICS Inc.
• 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	08800039006675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180992

FDA Product Code

• NBY: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

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: 2025-08-01
• Device Publish Date: 2025-07-24

On-Brand Devices [TBS PTFE Suture]

• 08800039006675: PTFE5022
• 08800039006668: PTFE4022
• 08800039006651: PTFE3022