Anatomic Shoulder TM Combined System SSI004358

GUDID 00889024509382

Zimmer, Inc.

Glenoid orthopaedic reamer

• Primary Device ID: 00889024509382
• NIH Device Record Key: 6d3bad75-96f5-49cd-8ea8-b83c1bed322b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anatomic Shoulder TM Combined System
• Version Model Number: SSI004358
• Catalog Number: SSI004358
• 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) 343-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024509382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103404

FDA Product Code

• KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

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

[00889024509382]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-08
• Device Publish Date: 2018-03-26

On-Brand Devices [Anatomic Shoulder TM Combined System]

• 00889024509405: SSI004361
• 00889024509399: SSI004359
• 00889024509382: SSI004358
• 00887868231230: 82-0180-119-52
• 00887868231223: 82-0180-119-46
• 00887868231216: 82-0180-119-40