BMT ASYMMETRIC PAT TEMPLATE SSI004631

GUDID 00887868262050

Biomet Orthopedics, LLC

Surgical implant template, reusable

• Primary Device ID: 00887868262050
• NIH Device Record Key: 91c760a1-e372-47b1-b0e3-96d422acecdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BMT ASYMMETRIC PAT TEMPLATE
• Version Model Number: SSI004631
• Catalog Number: SSI004631
• 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: 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) 343-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868262050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110362

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[00887868262050]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-24
• Device Publish Date: 2018-08-22

Devices Manufactured by Biomet Orthopedics, LLC

• 00887868004087 - PRIMARY TREPHINE: 2024-04-03
• 00887868004094 - BUSHING: 2024-04-03
• 00887868004100 - SECONDARY TREPHINE: 2024-04-03
• 00887868048272 - TREPHINE: 2024-04-03
• 00887868048289 - TREPHINE: 2024-04-03
• 00887868048296 - TREPHINE: 2024-04-03
• 00887868048302 - TREPHINE: 2024-04-03
• 00880304658387 - Compress®: 2024-03-11