SutureTOOL

GUDID 07350154050004

Suturion AB

Suturing unit, single-use

• Primary Device ID: 07350154050004
• NIH Device Record Key: a851778b-0009-4e2d-898c-848d32ca6361
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SutureTOOL
• Version Model Number: BOM 1018S rev 10 SutureTOOL
• Company DUNS: 353236163
• Company Name: Suturion AB
• 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: true
• 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	07350154050004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242835

FDA Product Code

• GAB: Needle, Suturing, Disposable

Sterilization

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

[07350154050004]

Ethylene Oxide

[07350154050004]

Ethylene Oxide

[07350154050004]

Ethylene Oxide

[07350154050004]

Ethylene Oxide

[07350154050004]

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