Avenir Complete™ 574999060
GUDID 00889024510166
Zimmer, Inc.
Bone file/rasp, manual| Primary Device ID | 00889024510166 |
| NIH Device Record Key | a853e60f-f254-468b-a30e-0a7e5796517e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avenir Complete™ |
| Version Model Number | 574999060 |
| Catalog Number | 574999060 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
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 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 | 00889024510166 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182048
FDA Product Code
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
[00889024510166]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-26 |
| Device Publish Date | 2019-06-18 |
On-Brand Devices [Avenir Complete™]
Trademark Results [Avenir Complete]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVENIR COMPLETE 87563759 not registered Live/Pending |
Zimmer GmbH 2017-08-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.