Champion Suture Passer Needle

GUDID 00860794002655

Champion Passer Needle - single needle

Lincotek Medical LLC

Suturing needle, single-use

• Primary Device ID: 00860794002655
• NIH Device Record Key: 02325058-e75a-47f6-ac33-1b698d4bb370
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Champion Suture Passer Needle
• Version Model Number: 3910-900-091
• Company DUNS: 117021487
• Company Name: Lincotek Medical LLC
• Device Count: 1
• DM Exempt: true
• 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
GS1	00860794002655 [Primary]
GS1	10860794002652 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• GAB: Needle, Suturing, Disposable

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: 2023-12-26
• Device Publish Date: 2023-12-18

Devices Manufactured by Lincotek Medical LLC

• 00860794002679 - Versipass Suture Passer Needle: 2024-10-25 Suture passer needle for the Versipass Suture Passer
• 00860794002600 - Champion Suture Passer Ratchet Straight: 2024-01-10 Champion Suture Passer Ratchet Straight
• 00860794002617 - Champion Suture Passer Ratchet Humpback: 2024-01-10 Champion Suture Passer Ratchet Humpback
• 00860794002624 - Champion Suture Passer Ratchet Straight Capture: 2024-01-10 Champion Suture Passer Ratchet Straight Capture
• 00860794002631 - Champion Suture Passer Ratchet Humpback Capture: 2024-01-10 Champion Suture Passer Ratchet Humpback Capture
• 00860794002655 - Champion Suture Passer Needle: 2023-12-26Champion Passer Needle - single needle
• 00860794002655 - Champion Suture Passer Needle: 2023-12-26 Champion Passer Needle - single needle
• 00860794002662 - Versipass Suture Passer: 2023-12-20 The VersiPass Suture Passer instrument is a reusable manual surgical instrument used to pass sutures for arthroscopic and open r