| 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 |
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| 17310230102789 - Ceramir Crown & Bridge QuikMix | 2024-04-05 Ceramir Crown & Bridge QuikMix Liquid 10g |
| 17310230400373 - Ceramir BIC QuikCap | 2024-04-05 Ceramir BIC QuikCap Capsule |
| 17310230400328 - Ceramir Crown & Bridge QuikMix | 2024-04-05 Ceramir Crown & Bridge QuikMix Kit |
| 17310230021318 - Luxator | 2022-12-15 17310231050416 17310231050423 17310231050430 17310231050447 |