Trabecular Metal™ 00-4309-046-01

GUDID 00889024405219

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024405219
• NIH Device Record Key: 2c16ab9e-e6db-458a-a58e-e502fb097383
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trabecular Metal™
• Version Model Number: 00-4309-046-01
• Catalog Number: 00-4309-046-01
• 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: 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00889024405219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052906

FDA Product Code

• KWT: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

[00889024405219]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-09
• Device Publish Date: 2016-08-08

On-Brand Devices [Trabecular Metal™]

• 00889024197671: 00-5852-041-35
• 00889024197664: 00-5852-041-30
• 00889024197657: 00-5852-040-35
• 00889024197640: 00-5852-040-30
• 00889024197633: 00-5852-040-25
• 00889024267749: 00-4309-050-01
• 00889024435599: 00-4511-080-00
• 00889024435568: 00-4312-019-02
• 00889024435551: 00-4312-018-02
• 00889024435520: 00-4309-045-20
• 00889024405608: 00-4350-018-20
• 00889024405592: 00-4350-017-13
• 00889024405219: 00-4309-046-01
• 00889024405196: 00-4501-000-25
• 00889024405189: 00-4501-000-10
• 00889024405134: 4309-01
• 00889024271180: 00-4501-083-00
• 00889024271173: 00-4501-082-00
• 00889024271166: 00-4501-081-00
• 00889024271159: 00-4501-080-00
• 00889024271142: 00-4501-078-01
• 00889024271135: 00-4501-077-00
• 00889024271128: 00-4501-076-01
• 00889024271111: 00-4501-076-00
• 00889024271104: 00-4501-075-00
• 00889024271098: 00-4501-073-00
• 00889024271081: 00-4501-072-00
• 00889024271074: 00-4501-071-00
• 00889024271067: 00-4501-070-00
• 00889024271050: 00-4501-067-03
• 00889024271043: 00-4501-067-01
• 00889024271036: 00-4501-065-01
• 00889024271029: 00-4501-065-00
• 00889024271012: 00-4501-060-02
• 00889024271005: 00-4501-060-01
• 00889024270992: 00-4501-059-00
• 00889024270985: 00-4501-058-01
• 00889024270978: 00-4501-058-00
• 00889024270961: 00-4501-057-05
• 00889024270954: 00-4501-057-00
• 00889024270947: 00-4501-056-00
• 00889024270930: 00-4501-055-00
• 00889024270923: 00-4501-054-00
• 00889024270916: 00-4501-053-04
• 00889024270909: 00-4501-053-03
• 00889024270893: 00-4501-053-02
• 00889024270886: 00-4501-053-01
• 00889024270879: 00-4501-052-03
• 00889024270862: 00-4501-052-02
• 00889024270855: 00-4501-052-01