Vivacit-E® 110031020
GUDID 00889024572782
Zimmer, Inc.
Non-constrained polyethylene acetabular liner| Primary Device ID | 00889024572782 |
| NIH Device Record Key | 49f0ab59-f6fa-4385-92a0-27da0576a669 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vivacit-E® |
| Version Model Number | 110031020 |
| Catalog Number | 110031020 |
| 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 |
| zimmer.consumerrelations@zimmerbiomet.com |
Device Dimensions
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024572782 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190656
FDA Product Code
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
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 | 2020-01-08 |
| Device Publish Date | 2019-12-31 |
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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