Suture USP 0

GUDID 17350154050551

Suturion AB

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 17350154050551
• NIH Device Record Key: 9e11e4e1-5a5b-43de-ae5f-3337c70476d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suture USP 0
• Version Model Number: BOM 1055S rev 05 Suture PDO USP 0 - Sterilized
• Company DUNS: 353236163
• Company Name: Suturion AB
• Device Count: 12
• 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: true
• 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	07350154050554 [Unit of Use]
GS1	17350154050551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250977

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

Sterilization

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

[17350154050551]

Ethylene Oxide

[17350154050551]

Ethylene Oxide

[17350154050551]

Ethylene Oxide

[17350154050551]

Ethylene Oxide

[17350154050551]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-23
• Device Publish Date: 2025-12-15

Devices Manufactured by Suturion AB

• 07350154050004 - SutureTOOL: 2025-12-23
• 17350154050513 - Suture USP 2-0: 2025-12-23
• 17350154050551 - Suture USP 0: 2025-12-23
• 17350154050551 - Suture USP 0: 2025-12-23