| Primary Device ID | 17310236027536 |
| NIH Device Record Key | 8ed3ab8f-ab05-465b-8d79-e838f8ae9c23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FenderWedge |
| Version Model Number | Large |
| Catalog Number | 602753 |
| 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 | 17310236027536 [Primary] |
| EJB | Handle, Instrument, Dental |
| 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 |
| 17310236027369 | NG Orange |
| 17310236027352 | NG Purple |
| 17310236028113 | Prep Value Pack |
| 17310236028038 | Value Pack |
| 17310236028021 | Value Pack |
| 17310236028014 | Value Pack |
| 17310236028007 | Value Pack |
| 17310236027543 | X-small |
| 17310236027536 | Large |
| 17310236027529 | Medium |
| 17310236027512 | Small |
| 17310236027505 | Assortment |
| 17310236027499 | Prep |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FENDERWEDGE 79027123 3312815 Live/Registered |
Directa AB 2006-01-25 |