LogiFlex - Laparoscopic Instrument System

GUDID 05051986011288

Gastric Band Positioning Device 455mm

SURGICAL INNOVATIONS LIMITED

Laparoscopic blunt dissector

• Primary Device ID: 05051986011288
• NIH Device Record Key: c58a8b3d-fce6-4045-bc23-a14a1a5078b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LogiFlex - Laparoscopic Instrument System
• Version Model Number: 120-7200
• Company DUNS: 771051935
• Company Name: SURGICAL INNOVATIONS LIMITED
• 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: 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	05051986002712 [Primary]
GS1	05051986011288 [Package]; Contains: 05051986002712; Package: Inner box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100109

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-30
• Device Publish Date: 2016-09-23

Devices Manufactured by SURGICAL INNOVATIONS LIMITED

• 05051986012940 - Logi - Laparoscopic Instrument System: 2022-12-01 LogiCut Scissor Length 320mm (non-PVC cap)
• 05051986012988 - Logi - Laparoscopic Instrument System: 2022-12-01 LogiCut Scissor Length 240mm (non-PVC cap)
• 05051986013008 - Logi - Laparoscopic Instrument System: 2022-12-01 LogiCut Scissor Length 450mm (Non-PVC Cap)
• 05051986013398 - YelloPort Elite: 2022-05-17 5x70 Optical Trocar
• 05051986013411 - YelloPort Elite: 2022-05-17 5x 95 Optical Trocar
• 05051986013381 - YelloPort Elite: 2022-04-28 5x95 Cannula Threaded + Stopcock
• 05051986002088 - YelloPort Elite: 2022-04-27 10x105 Pencil Point Trocar
• 05051986012247 - YelloPort Elite: 2022-04-27 12x105 Optical Bladeless Port System