| Primary Device ID | 07333117000162 |
| NIH Device Record Key | 5d0242a8-9f0e-4e90-83be-8d3048db74cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lip Retractor |
| Version Model Number | LR-00-01 |
| Catalog Number | LR-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 |