TOGGLELOC WITH ZIPLOOP 909849

GUDID 00880304472709

Biomet Sports Medicine, LLC

Ligament reconstruction instrument set, reusable

• Primary Device ID: 00880304472709
• NIH Device Record Key: 7449d3de-8cd9-49d8-97fd-04f747cf882e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOGGLELOC WITH ZIPLOOP
• Version Model Number: 909849
• Catalog Number: 909849
• Company DUNS: 627100159
• Company Name: Biomet Sports Medicine, 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	00880304472709 [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: 5
• Public Version Date: 2019-02-21
• Device Publish Date: 2015-10-24

On-Brand Devices [TOGGLELOC WITH ZIPLOOP]

• 00880304676947: 110017308
• 00880304478923: 909874
• 00880304472709: 909849
• 00880304464773: 909848