PERSONA™ 42-5112-007-18

GUDID 00889024233935

Zimmer, Inc.

Tibial insert

• Primary Device ID: 00889024233935
• NIH Device Record Key: 0ddee5a6-7d2a-465a-a67d-9c6f49cb5ef6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERSONA™
• Version Model Number: 42-5112-007-18
• Catalog Number: 42-5112-007-18
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

• Height: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024233935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113369

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: 4
• Public Version Date: 2019-11-14
• Device Publish Date: 2015-09-17

On-Brand Devices [PERSONA™]

• 00889024247666: 42-5400-000-41
• 00889024247659: 42-5400-000-38
• 00889024247642: 42-5400-000-35
• 00889024247635: 42-5400-000-32
• 00889024247628: 42-5400-000-29
• 00889024247468: 42-5399-061-02
• 00889024247451: 42-5399-061-01
• 00889024247444: 42-5399-058-02
• 00889024247437: 42-5399-058-01
• 00889024247369: 42-5399-023-00
• 00889024246089: 42-5279-009-04
• 00889024246072: 42-5279-009-03
• 00889024246065: 42-5279-009-02
• 00889024246058: 42-5279-009-01
• 00889024246041: 42-5279-009-00
• 00889024245983: 42-5279-007-04
• 00889024245976: 42-5279-007-03
• 00889024245969: 42-5279-007-02
• 00889024245952: 42-5279-007-01
• 00889024245945: 42-5279-007-00
• 00889024245884: 42-5279-005-04
• 00889024245877: 42-5279-005-03
• 00889024245860: 42-5279-005-02
• 00889024245853: 42-5279-005-01
• 00889024245846: 42-5279-005-00
• 00889024245785: 42-5279-003-04
• 00889024245778: 42-5279-003-03
• 00889024245761: 42-5279-003-02
• 00889024245754: 42-5279-003-01
• 00889024245747: 42-5279-003-00
• 00889024245686: 42-5279-001-04
• 00889024245679: 42-5279-001-03
• 00889024245662: 42-5279-001-02
• 00889024245655: 42-5279-001-01
• 00889024245648: 42-5279-001-00
• 00889024245266: 42-5272-007-10
• 00889024245259: 42-5272-006-10
• 00889024245242: 42-5272-005-10
• 00889024245235: 42-5272-004-10
• 00889024245082: 42-5270-009-19
• 00889024245075: 42-5270-009-09
• 00889024245051: 42-5270-007-10
• 00889024245044: 42-5270-007-07
• 00889024245037: 42-5270-006-10
• 00889024245020: 42-5270-005-15
• 00889024245013: 42-5270-005-10
• 00889024245006: 42-5270-005-05
• 00889024244993: 42-5270-004-10
• 00889024244986: 42-5270-003-13
• 00889024244979: 42-5270-003-10