MUTARS® trial connecting part distal
GUDID 04048844146368
implantcast GmbH
General internal orthopaedic fixation system implantation kit| Primary Device ID | 04048844146368 |
| NIH Device Record Key | ba9ed37e-1bc8-4123-813f-4ca53efc5c69 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MUTARS® trial connecting part distal |
| Version Model Number | 7730010001 |
| Company DUNS | 324369826 |
| Company Name | implantcast GmbH |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048844146368 [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 | true |
| Device Is Sterile | false |
[04048844146368]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2019-04-01 |
Devices Manufactured by implantcast GmbH
| 04048844049881 - MUTARS® | 2024-11-15 femoral stem cemented |
| 04048844049898 - MUTARS® | 2024-11-15 femoral stem cemented |
| 04048844049911 - MUTARS® | 2024-11-15 femoral stem cemented |
| 04048844049928 - MUTARS® | 2024-11-15 femoral stem cemented |
| 04048844049942 - MUTARS® | 2024-11-15 femoral stem cemented |
| 04048844049959 - MUTARS® | 2024-11-15 femoral stem cemented |
| 04048844042844 - n/a | 2024-10-08 modular handle 'fast fix' |
| 04048844043032 - n/a | 2024-10-08 femoral/tibial extractor |
Trademark Results [MUTARS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MUTARS 79189818 5135143 Live/Registered |
implantcast GmbH 2016-05-17 |
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