Unicondylar Interpositional Spacer 82-0153-115-01

GUDID 00889024487031

Zimmer, Inc.

Orthopaedic retractor

• Primary Device ID: 00889024487031
• NIH Device Record Key: facbed47-8b4a-436c-8f8b-74f78653c69d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unicondylar Interpositional Spacer
• Version Model Number: 82-0153-115-01
• Catalog Number: 82-0153-115-01
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• 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: false
• Serial Number: true
• 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	00889024487031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003269

FDA Product Code

• HSH: Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

Sterilization

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

[00889024487031]

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: 2017-02-16

On-Brand Devices [Unicondylar Interpositional Spacer]

• 00889024487031: 82-0153-115-01
• 00889024487024: 82-0153-115-00