NexGen® Gender Solutions®

GUDID 00889024191495

Zimmer, Inc.

Coated knee femur prosthesis

• Primary Device ID: 00889024191495
• NIH Device Record Key: e4edbcc5-5f56-468e-a2d0-09548d08413b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexGen® Gender Solutions®
• Version Model Number: 00-5752-017-05
• 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@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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00889024191495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072619

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-17

On-Brand Devices [NexGen® Gender Solutions®]

• 00889024191488: 00-5752-017-02
• 00889024191471: 00-5752-017-01
• 00889024191440: 00-5752-016-02
• 00889024191433: 00-5752-016-01
• 00889024191402: 00-5752-015-02
• 00889024191396: 00-5752-015-01
• 00889024191389: 00-5752-014-06
• 00889024191808: 00-5755-017-92
• 00889024191792: 00-5755-017-91
• 00889024191785: 00-5755-017-06
• 00889024191778: 00-5755-017-05
• 00889024191761: 00-5755-017-02
• 00889024191754: 00-5755-017-01
• 00889024191747: 00-5755-016-92
• 00889024191730: 00-5755-016-91
• 00889024191723: 00-5755-016-06
• 00889024191716: 00-5755-016-05
• 00889024191709: 00-5755-016-02
• 00889024191693: 00-5755-016-01
• 00889024191686: 00-5755-015-92
• 00889024191679: 00-5755-015-91
• 00889024191662: 00-5755-015-06
• 00889024191655: 00-5755-015-05
• 00889024191648: 00-5755-015-02
• 00889024191631: 00-5755-015-01
• 00889024191624: 00-5755-014-92
• 00889024191617: 00-5755-014-91
• 00889024191600: 00-5755-014-06
• 00889024191594: 00-5755-014-05
• 00889024191587: 00-5755-014-02
• 00889024191570: 00-5755-014-01
• 00889024191563: 00-5755-013-92
• 00889024191556: 00-5755-013-91
• 00889024191549: 00-5755-013-06
• 00889024191532: 00-5755-013-05
• 00889024191525: 00-5755-013-02
• 00889024191518: 00-5755-013-01
• 00889024191501: 00-5752-017-06
• 00889024191495: 00-5752-017-05
• 00889024191464: 00-5752-016-06
• 00889024191457: 00-5752-016-05
• 00889024191426: 00-5752-015-06
• 00889024191419: 00-5752-015-05
• 00889024191372: 00-5752-014-05
• 00889024191365: 00-5752-014-02
• 00889024191358: 00-5752-014-01
• 00889024191341: 00-5752-013-06
• 00889024191334: 00-5752-013-05
• 00889024191327: 00-5752-013-02
• 00889024191310: 00-5752-013-01