| Primary Device ID | 08800038700062 |
| NIH Device Record Key | 5436b639-5de5-4a13-ab9b-3f9a562c8d15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VAROGuide PreGuide |
| Version Model Number | PGFM |
| Company DUNS | 688444000 |
| Company Name | DMS Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |