SIGNATURE INSTRUMENTATION 110004349

GUDID 00880304567610

Biomet Orthopedics, LLC

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00880304567610
• NIH Device Record Key: d23ac040-327e-4b64-ade1-438ee3b16e22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNATURE INSTRUMENTATION
• Version Model Number: 110004349
• Catalog Number: 110004349
• 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: true
• 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
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304567610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130126

FDA Product Code

• PAO: prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

Sterilization

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

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

[00880304567610]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-28

On-Brand Devices [SIGNATURE INSTRUMENTATION]

• 00880304716438: 42-422508
• 00880304716421: 42-422502
• 00880304567610: 110004349
• 00880304567603: 110004348
• 00880304539013: 110004347