N/A

GUDID 00889024261815

Zimmer, Inc.

Tibial insert

• Primary Device ID: 00889024261815
• NIH Device Record Key: 50aed3e9-f164-4c1c-9864-5482e04c7ab8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 6811-00-016
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024261815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934381

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-17

On-Brand Devices [N/A]

• 00889024197992: 00-5852-054-19
• 00889024197985: 00-5852-054-18
• 00889024197978: 00-5852-054-17
• 00889024197961: 00-5852-054-16
• 00889024197954: 00-5852-054-15
• 00889024197947: 00-5852-054-14
• 00889024197930: 00-5852-054-13
• 00889024197923: 00-5852-054-12
• 00889024197916: 00-5852-052-19
• 00889024197909: 00-5852-052-18
• 00889024197893: 00-5852-052-17
• 00889024197886: 00-5852-052-16
• 00889024197879: 00-5852-052-15
• 00889024197862: 00-5852-052-14
• 00889024197855: 00-5852-052-13
• 00889024197848: 00-5852-052-12
• 00889024197800: 00-5852-050-19
• 00889024197794: 00-5852-050-18
• 00889024197787: 00-5852-050-17
• 00889024197770: 00-5852-050-16
• 00889024197763: 00-5852-050-15
• 00889024197756: 00-5852-050-14
• 00889024197749: 00-5852-050-13
• 00889024197732: 00-5852-050-12
• 00889024197695: 00-5852-042-17
• 00889024197688: 00-5852-042-09
• 00889024196308: 00-5850-070-13
• 00889024196292: 00-5850-070-12
• 00889024196285: 00-5850-060-26
• 00889024196278: 00-5850-060-23
• 00889024196261: 00-5850-060-20
• 00889024196254: 00-5850-060-17
• 00889024196247: 00-5850-060-14
• 00889024196230: 00-5850-060-12
• 00889024196223: 00-5850-050-26
• 00889024196216: 00-5850-050-23
• 00889024196209: 00-5850-050-20
• 00889024196193: 00-5850-050-17
• 00889024196186: 00-5850-050-14
• 00889024196179: 00-5850-050-12
• 00889024196162: 00-5850-048-20
• 00889024196155: 00-5850-048-09
• 00889024196148: 00-5850-048-08
• 00889024196124: 00-5850-046-45
• 00889024196117: 00-5850-046-35
• 00889024196100: 00-5850-046-22
• 00889024196094: 00-5850-046-20
• 00889024196087: 00-5850-046-18
• 00889024196070: 00-5850-046-16
• 00889024196063: 00-5850-046-14