32-8105-035-06

GUDID 00889024274044

Zimmer, Inc.

Hinged total elbow prosthesis

• Primary Device ID: 00889024274044
• NIH Device Record Key: d167ce46-e13d-42a6-a999-a3435babbb7d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 32-8105-35-06
• Catalog Number: 32-8105-035-06
• 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: 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@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

• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024274044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001989

FDA Product Code

• JDC: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-10
• Device Publish Date: 2015-09-17

Devices Manufactured by Zimmer, Inc.

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• 00889024673939 - Modified PSN Fem 4-in-1 Cut Block SZ 3: 2024-07-29
• 00889024673946 - Modified PSN Fem 4-in-1 Cut Block SZ 4: 2024-07-29
• 00889024673953 - Modified PSN Fem 4-in-1 Cut Block SZ 5: 2024-07-29
• 00889024673960 - Modified PSN Fem 4-in-1 Cut Block SZ 6: 2024-07-29
• 00889024673977 - Modified PSN Fem 4-in-1 Cut Block SZ 7: 2024-07-29
• 00889024673984 - Modified PSN Fem 4-in-1 Cut Block SZ 8: 2024-07-29
• 00889024673991 - Modified PSN Fem 4-in-1 Cut Block SZ 9: 2024-07-29