EXPRESSBRAID GRAFT MANIPULATION 110003464

GUDID 00880304566675

Biomet Orthopedics, LLC

Operative-site suture holder

• Primary Device ID: 00880304566675
• NIH Device Record Key: 093c9493-4f72-476c-a055-2fb95f344d2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPRESSBRAID GRAFT MANIPULATION
• Version Model Number: 110003464
• Catalog Number: 110003464
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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: 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	00880304566675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152868

FDA Product Code

• GAT: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-06-11

On-Brand Devices [EXPRESSBRAID GRAFT MANIPULATION]

• 00880304566675: 110003464
• 00880304566668: 110003463