ToggleLoc with Ziploop 904753

GUDID 00880304469471

Biomet Orthopedics, LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00880304469471
• NIH Device Record Key: bba3f7cc-603c-49e2-b9b9-3704980d72e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ToggleLoc with Ziploop
• Version Model Number: 904753
• Catalog Number: 904753
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304469471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033838

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: 2020-05-11
• Device Publish Date: 2015-10-24

On-Brand Devices [ToggleLoc with Ziploop]

• 00880304676930: 110010384
• 00880304470361: 909854
• 00880304469471: 904753
• 00880304464858: 904754
• 00880304464223: 904756
• 00880304453364: 904755