EXACT 31-555588

GUDID 00880304432710

Biomet Orthopedics, LLC

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00880304432710
• NIH Device Record Key: 98654dca-c6a1-4597-9d90-a4c241ffd58d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXACT
• Version Model Number: 31-555588
• Catalog Number: 31-555588
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00880304432710 [Primary]

FDA Product Code

• FZO: CHISEL, SURGICAL, MANUAL

Sterilization

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

[00880304432710]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-09
• Device Publish Date: 2017-07-28

On-Brand Devices [EXACT]

• 00880304432710: 31-555588
• 00887868259838: SSI004283