Vivacit-E® 00-5842-093-08
GUDID 00889024517646
Zimmer, Inc.
Unicondylar knee insert| Primary Device ID | 00889024517646 |
| NIH Device Record Key | 7d3ac855-6926-4295-a302-6ab8524f3e4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vivacit-E® |
| Version Model Number | 00-5842-093-08 |
| Catalog Number | 00-5842-093-08 |
| 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 |
| zimmer.consumerrelations@zimmerbiomet.com |
Device Dimensions
| Height | 8 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024517646 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122529
FDA Product Code
| HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-15 |
| Device Publish Date | 2018-09-14 |
On-Brand Devices [Vivacit-E®]
Trademark Results [Vivacit-E]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIVACIT-E 85359927 4091088 Live/Registered |
Zimmer, Inc. 2011-06-29 |
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