Asym Pat Drill Gde SSI005437

GUDID 00889024588257

Biomet Orthopedics, LLC

Surgical drill guide, reusable

• Primary Device ID: 00889024588257
• NIH Device Record Key: a0f35823-ac1c-4fd0-8d9f-1bad03a418de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Asym Pat Drill Gde
• Version Model Number: SSI005437
• Catalog Number: SSI005437
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024588257 [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

[00889024588257]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-26
• Device Publish Date: 2020-02-18

On-Brand Devices [Asym Pat Drill Gde]

• 00889024588264: SSI005438
• 00889024588257: SSI005437