MUTARS® proximal femur
GUDID 04048844428549
implantcast GmbH
Uncoated hip femur prosthesis, modular| Primary Device ID | 04048844428549 |
| NIH Device Record Key | 9dece881-3674-4dfa-9046-ed87b7001e5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MUTARS® proximal femur |
| Version Model Number | 5710020700 |
| Company DUNS | 324369826 |
| Company Name | implantcast GmbH |
| 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 |
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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048844428549 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181778
FDA Product Code
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-05-08 |
| Device Publish Date | 2019-04-05 |
On-Brand Devices [MUTARS® proximal femur]
| 04048844426934 | 5710020700 |
| 04048844426897 | 5710020500 |
| 04048844428549 | 5710020700 |
Trademark Results [MUTARS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MUTARS 79189818 5135143 Live/Registered |
implantcast GmbH 2016-05-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.