Reprocessed SutureLasso, 45 Deg, Curve Left

GUDID B390AR406845L1

SURETEK MEDICAL

Suturing unit, reusable

• Primary Device ID: B390AR406845L1
• NIH Device Record Key: aff9992c-4285-4d5b-95d8-9035b7ab8891
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed SutureLasso, 45 Deg, Curve Left
• Version Model Number: AR-4068-45L
• Company DUNS: 785616934
• Company Name: SURETEK MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
HIBCC	B390AR406845L1 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

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: 2024-12-23
• Device Publish Date: 2024-12-13

Devices Manufactured by SURETEK MEDICAL

• B39016005401 - Reprocessed Shaver Blade Straight 4.0mm Double Serrated: 2025-06-30
• B39062901120401 - Reprocessed 4mm Straight Shaver Blade: 2025-06-13
• B39062902080251 - Reprocessed 2.5mm Straight Shaver Blade: 2025-06-13
• B39072053121 - Reprocessed 3.5mm Incisor Blade: 2025-06-13
• B39016005381 - Reprocessed Shaver Blade Straight 3.0mm Double Serrated: 2025-06-09
• B39016010701 - Reprocessed Shaver Blade Straight 2.1mm Double Serrated: 2025-06-09
• B3902833091 - Reprocessed 3.5mm Full Radius Blade Plus: 2025-06-02 3.5mm Full Radius Blade Plus, Yellow
• B3902834091 - Reprocessed 4.0mm Full Radius Blade Plus: 2025-06-02 4.0mm Full Radius Blade Plus, 13cm, Yellow