SIGNATURE ACETABULAR 42-100105

GUDID 00880304516281

Biomet Orthopedics, LLC

Surgical drill guide, reusable

• Primary Device ID: 00880304516281
• NIH Device Record Key: d1643abd-97c0-4d2b-b105-247bd040d676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNATURE ACETABULAR
• Version Model Number: 42-100105
• Catalog Number: 42-100105
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304516281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111863

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[00880304516281]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-10-25

On-Brand Devices [SIGNATURE ACETABULAR]

• 00880304516311: 42-100106
• 00880304516281: 42-100105