110046268

GUDID 00889024632332

Zimmer, Inc.

Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

• Primary Device ID: 00889024632332
• NIH Device Record Key: dc549850-6cc1-4a77-ab86-a47a7b6287df
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 110046268
• Catalog Number: 110046268
• 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: 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)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@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 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	00889024632332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221479

FDA Product Code

• OIY: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Sterilization

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

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

[00889024632332]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-01
• Device Publish Date: 2022-11-23

Devices Manufactured by Zimmer, Inc.

• 00889024648180 - ROSA® Shoulder: 2024-02-29
• 00889024648197 - ROSA® Shoulder: 2024-02-29
• 00889024648203 - ROSA® Shoulder: 2024-02-29
• 00889024625877 - G7 25MM DRILL GUIDE: 2023-12-25
• 00889024657441 - RDCTN HNDL ASSY LRG: 2023-12-25
• 00889024658004 - PIVOTING HUMERAL EM GUIDE: 2023-12-25
• 00889024660571 - 3.5MM BALL HEX SHAFT: 2023-12-25
• 00889024661257 - REAMER ADPT PULLER: 2023-12-25