ExpressBraid™ Graft Manipulation 110003464

GUDID 70887868462565

Biomet Orthopedics, LLC

Operative-site suture holder Operative-site suture holder Operative-site suture holder Operative-site suture holder Operative-site suture holder Operative-site suture holder Operative-site suture holder

• Primary Device ID: 70887868462565
• NIH Device Record Key: 1a6147b6-3934-4ed0-9ef6-f7dc1ef05dc9
• 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: 10
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868462566 [Primary]
GS1	70887868462565 [Unit of Use]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-27
• Device Publish Date: 2021-07-19

On-Brand Devices [ExpressBraid™ Graft Manipulation]

• 70887868462565: 110003464
• 00887868462689: 110003540
• 00887868462672: 110003539