| Primary Device ID | 17310236026799 |
| NIH Device Record Key | ea35bc3c-4f52-4974-b9c3-398735f36c4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FenderWedge & FenderMate |
| Version Model Number | Intro-Kit |
| Catalog Number | 602679 |
| Company DUNS | 353954381 |
| Company Name | Directa AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17310236026799 [Primary] |
| JEP | Retainer, Matrix |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| 17310231029993 - ProphyCare HAp | 2025-09-09 ProphyCare HAp in single dose disposable cups |
| 17310230021639 - Luxator | 2025-02-27 17310231050461 17310231050430 17310231050416 17310231050454 17310231050478 17310231050447 17310231050423 |
| 17310230021646 - Luxator | 2025-02-27 17310231050485 17310231050461 17310231050430 17310231050416 17310231050454 |
| 17310230021196 - TrollBag | 2024-07-25 |
| 17310230021202 - Camera Sleeve | 2024-07-25 |
| 17310230400304 - Ceramir Crown & Bridge QuikCap | 2024-04-05 Ceramir Crown & Bridge QuikCap Capsule |
| 17310230102772 - Ceramir Crown & Bridge QuikMix | 2024-04-05 Ceramir Crown & Bridge QuikMix Powder 15g |
| 17310230102789 - Ceramir Crown & Bridge QuikMix | 2024-04-05 Ceramir Crown & Bridge QuikMix Liquid 10g |