ToggleLoc™ With Ziploop™ 909849

GUDID 00880304979598

Biomet Orthopedics, LLC

Ligament reconstruction instrument set, reusable

• Primary Device ID: 00880304979598
• NIH Device Record Key: 2d736ed6-4030-4fd7-8829-cca882aee963
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ToggleLoc™ With Ziploop™
• Version Model Number: 909849
• Catalog Number: 909849
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304979598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083070

FDA Product Code

• MBI: Fastener, fixation, nondegradable, soft tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-05-11
• Device Publish Date: 2017-05-04

On-Brand Devices [ToggleLoc™ With Ziploop™]

• 00880304979598: 909849
• 00880304979581: 909848
• 00880304863422: 909874
• 00880304812895: 110017308
• 00880304812864: 110010384
• 00880304568341: 110007421
• 00880304812888: 110017307
• 00880304812871: 110017306
• 00880304812833: 110010379
• 00880304812949: 110026848