ROSA Comp Mini Reamer - Step 1 SSI007723

GUDID 00889024680869

Zimmer, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00889024680869
• NIH Device Record Key: 9b7fda49-7573-4f6a-b62a-2fd48f55ed06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROSA Comp Mini Reamer - Step 1
• Version Model Number: SSI007723
• Catalog Number: SSI007723
• 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
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024680869 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233199

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

[00889024680869]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-09
• Device Publish Date: 2024-08-30

Devices Manufactured by Zimmer, Inc.

• 00887868585661 - Zimmer Biomet® 12/14 Spherical Head Trials: 2024-11-19
• 00887868139628 - Affixus®: 2024-11-18
• 00887868139635 - Affixus®: 2024-11-18
• 00887868139642 - Affixus®: 2024-11-18
• 00887868139659 - Affixus®: 2024-11-18
• 00887868139666 - Affixus®: 2024-11-18
• 00887868139673 - Affixus®: 2024-11-18
• 00887868139680 - Affixus®: 2024-11-18