Reprocessed QuickPass SutureLasso, 45 Deg, Curve, Left, w/out Nitinol Wire

GUDID B390AR606845LX1

SURETEK MEDICAL

Suturing unit, reprocessed

• Primary Device ID: B390AR606845LX1
• NIH Device Record Key: eb758ff2-2a95-4eb0-9ab4-e490bc5388c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed QuickPass SutureLasso, 45 Deg, Curve, Left, w/out Nitinol Wire
• Version Model Number: AR-6068-45L-X
• 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	B390AR606845LX1 [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: 2024-09-16
• Device Publish Date: 2024-09-06

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