GUDID 00889024092297

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024092297
• NIH Device Record Key: 63cb9c60-6bb4-425d-bbe5-153baa6f4991
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 47-2366-080-00
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 3
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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@zimmer.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

• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter
• Device Size Text, specify: 0
• Length: 102 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024092297 [Primary]
GS1	00889024466111 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133246

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

Devices Manufactured by Zimmer, Inc.

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• 00889024678750 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678767 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678774 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678781 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678798 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678804 - OsseoFit™ Stemless Shoulder: 2024-12-26