TM Reverse Shoulder system 82-0180-132-00

GUDID 00889024471405

Zimmer, Inc.

Medullary canal orthopaedic reamer, flexible

• Primary Device ID: 00889024471405
• NIH Device Record Key: 082e615b-e261-4ec1-8d89-aa484ec0bf95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TM Reverse Shoulder system
• Version Model Number: 82-0180-132-00
• Catalog Number: 82-0180-132-00
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00889024471405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133378

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

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

[00889024471405]

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: 2016-11-18

On-Brand Devices [TM Reverse Shoulder system]

• 00889024486522: 82-0180-135-00
• 00889024471412: 82-0180-033-03
• 00889024471405: 82-0180-132-00
• 00889024471382: 82-0180-134-00