Gender Solutions® 00-5926-011-01

GUDID 00889024205819

Zimmer, Inc.

Patellofemoral joint prosthesis

• Primary Device ID: 00889024205819
• NIH Device Record Key: 3a603605-945d-409d-864b-3bc6b2dc8cc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gender Solutions®
• Version Model Number: 00-5926-011-01
• Catalog Number: 00-5926-011-01
• 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: 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024205819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070695

FDA Product Code

• KRR: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-25
• Device Publish Date: 2017-10-09

On-Brand Devices [Gender Solutions®]

• 00889024205901: 00-5926-015-02
• 00889024205895: 00-5926-015-01
• 00889024205888: 00-5926-014-02
• 00889024205871: 00-5926-014-01
• 00889024205864: 00-5926-013-02
• 00889024205857: 00-5926-013-01
• 00889024205840: 00-5926-012-02
• 00889024205833: 00-5926-012-01
• 00889024205826: 00-5926-011-02
• 00889024205819: 00-5926-011-01
• 00889024439214: 00-5752-050-00
• 00889024206304: 00-5927-095-00
• 00889024206298: 00-5927-093-00
• 00889024206281: 00-5927-090-00
• 00889024206274: 00-5927-080-00
• 00889024206267: 00-5927-065-02
• 00889024206250: 00-5927-065-01
• 00889024206243: 00-5927-064-02
• 00889024206236: 00-5927-064-01
• 00889024206229: 00-5927-063-02
• 00889024206212: 00-5927-063-01
• 00889024206205: 00-5927-062-02
• 00889024206199: 00-5927-062-01
• 00889024206182: 00-5927-061-02
• 00889024206175: 00-5927-061-01
• 00889024206168: 00-5927-060-00
• 00889024206151: 00-5927-050-10
• 00889024206144: 00-5927-050-00
• 00889024206137: 00-5927-045-02
• 00889024206120: 00-5927-045-01
• 00889024206113: 00-5927-044-02
• 00889024206106: 00-5927-044-01
• 00889024206090: 00-5927-043-02
• 00889024206083: 00-5927-043-01
• 00889024206076: 00-5927-042-02
• 00889024206069: 00-5927-042-01
• 00889024206052: 00-5927-041-02
• 00889024206045: 00-5927-041-01
• 00889024206021: 00-5927-032-00
• 00889024206014: 00-5927-030-00
• 00889024206007: 00-5927-015-02
• 00889024205994: 00-5927-015-01
• 00889024205987: 00-5927-014-02
• 00889024205970: 00-5927-014-01
• 00889024205963: 00-5927-013-02
• 00889024205956: 00-5927-013-01
• 00889024205949: 00-5927-012-02
• 00889024205932: 00-5927-012-01
• 00889024205925: 00-5927-011-02
• 00889024205918: 00-5927-011-01