GUDID 00889024301856

Reamer for humeral stem 12

Zimmer GmbH

Joint prosthesis implantation kit, reusable

• Primary Device ID: 00889024301856
• NIH Device Record Key: 2aaf862d-182b-44aa-9e3f-5278e5c2b8aa
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 72.02.20-12
• Company DUNS: 488133448
• Company Name: Zimmer GmbH
• 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@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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00889024301856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142403

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

[00889024301856]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-14
• Device Publish Date: 2016-09-24

Devices Manufactured by Zimmer GmbH

• 00889024292512 - NCB®: 2024-05-13
• 00889024292550 - NCB®: 2024-05-13
• 00889024296558 - NCB®: 2024-05-13
• 00889024296565 - NCB®: 2024-05-13
• 00889024296572 - NCB®: 2024-05-13
• 00889024593152 - Wagner Cone Prosthesis®: 2023-12-20
• 00889024593176 - Wagner Cone Prosthesis®: 2023-12-20
• 00889024593183 - Wagner Cone Prosthesis®: 2023-12-20