| Primary Device ID | 00613732114268 |
| NIH Device Record Key | d0120ac8-39fb-422f-9dd2-5041e24f4dc6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROHO ENHANCER Cushion |
| Version Model Number | ENH1012C |
| Company DUNS | 006614792 |
| Company Name | Roho, Inc. |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613732114268 [Primary] |
| KIC | Cushion, Flotation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-24 |
| Device Publish Date | 2025-03-15 |
| 00613732057268 | ENHDEMO |
| 00613732056810 | ENH1011C |
| 00613732053338 | ENHMODIFIED |
| 00613732037314 | ENH1110C |
| 00613732001148 | ENH99C |
| 00613732001117 | ENH99DMC |
| 00613732001094 | ENH98C |
| 00613732001063 | ENH910C |
| 00613732001025 | ENH89C |
| 00613732000974 | ENH88C |
| 00613732000868 | ENH109C |
| 00613732000837 | ENH109DMC |
| 00613732000813 | ENH1010C |
| 00613732000790 | ENH1010DMC |
| 00613732000776 | ENHSMC |
| 00613732000745 | ENHLGC |
| 00613732000691 | ENHCUSTC |
| 00613732114268 | ENH1012C |
| 00613732114244 | ENH810C |
| 00613732113674 | ENH911C |
| 00613732113650 | ENH1111C |