| Primary Device ID | 07333117000148 |
| NIH Device Record Key | 7ed3307b-0ba5-4054-b6cf-15d7f9573faf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cheek retractor |
| Version Model Number | CR-00-01 |
| Catalog Number | CR-00-01 |
| Company DUNS | 354936098 |
| Company Name | Gestenco International 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07333117000148 [Primary] |
| EIF | Accessories, Retractor, 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 | 2020-10-23 |
| Device Publish Date | 2020-10-15 |
| 07333117000032 - SmartBond | 2020-10-23 |
| 07333117000049 - SmartBond | 2020-10-23 |
| 07333117000056 - SmartBond LC | 2020-10-23 |
| 07333117000063 - SmartBond LC | 2020-10-23 |
| 07333117000148 - Cheek retractor | 2020-10-23 |
| 07333117000148 - Cheek retractor | 2020-10-23 |
| 07333117000162 - Lip Retractor | 2020-10-23 |
| 07333117000179 - Lip Retractor | 2020-10-23 |
| 07333117000087 - Freddy | 2020-10-22 |