Gender Solutions® Natural-Knee® 00-5414-015-01

GUDID 00889024189164

Zimmer, Inc.

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 00889024189164
• NIH Device Record Key: 7e401dd5-35e6-4963-b212-d76c01358da0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gender Solutions® Natural-Knee®
• Version Model Number: 00-5414-015-01
• Catalog Number: 00-5414-015-01
• 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	00889024189164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070214

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/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: 6
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-09-17

On-Brand Devices [Gender Solutions® Natural-Knee®]

• 00889024573666: 00-5418-000-03
• 00889024573659: 00-5418-000-02
• 00889024573642: 00-5418-000-01
• 00889024573635: 00-5418-000-00
• 00889024189416: 00-5416-017-02
• 00889024189379: 00-5416-015-02
• 00889024189218: 00-5414-017-02
• 00889024189126: 00-5414-013-01
• 00889024188648: 00-5412-017-02
• 00889024188631: 00-5412-017-01
• 00889024188624: 00-5412-016-02
• 00889024188617: 00-5412-016-01
• 00889024188600: 00-5412-015-02
• 00889024188594: 00-5412-015-01
• 00889024188587: 00-5412-014-02
• 00889024188433: 00-5410-017-01
• 00889024344709: 00-5413-020-03
• 00889024191006: 00-5429-023-19
• 00889024190993: 00-5429-023-16
• 00889024190986: 00-5429-023-13
• 00889024190979: 00-5429-023-11
• 00889024190962: 00-5429-023-09
• 00889024190955: 00-5429-021-19
• 00889024190948: 00-5429-021-16
• 00889024190931: 00-5429-021-13
• 00889024190924: 00-5429-021-11
• 00889024190917: 00-5429-021-09
• 00889024190900: 00-5429-020-19
• 00889024190894: 00-5429-020-16
• 00889024190887: 00-5429-020-13
• 00889024190870: 00-5429-020-11
• 00889024190863: 00-5429-020-09
• 00889024190856: 00-5429-013-19
• 00889024190849: 00-5429-013-16
• 00889024190832: 00-5429-013-13
• 00889024190825: 00-5429-013-11
• 00889024190818: 00-5429-013-09
• 00889024190801: 00-5429-011-19
• 00889024190795: 00-5429-011-16
• 00889024190788: 00-5429-011-13
• 00889024190771: 00-5429-011-11
• 00889024190764: 00-5429-011-09
• 00889024190757: 00-5429-010-19
• 00889024190740: 00-5429-010-16
• 00889024190733: 00-5429-010-13
• 00889024190726: 00-5429-010-11
• 00889024190719: 00-5429-010-09
• 00889024190405: 00-5427-021-19
• 00889024190399: 00-5427-021-16
• 00889024190382: 00-5427-021-13