| Primary Device ID | 10067981957522 |
| NIH Device Record Key | 8c393e97-3b2d-45eb-a644-80eb0f293b18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUREX Pleasure Ring |
| Version Model Number | Penile Rigidity Ring |
| Company DUNS | 081049410 |
| Company Name | RB Health (us) LLC |
| 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 | true |
| 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 | true |
| Phone | +1(800)756-5488 |
| xxx@xxx.xxx |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight and corrosive chemicals and avoid extremes of heat and cold |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00067981957525 [Primary] |
| GS1 | 10067981957522 [Package] Contains: 00067981957525 Package: Carton [3 Units] In Commercial Distribution |
| GS1 | 20067981957529 [Package] Package: Case [8 Units] In Commercial Distribution |
| LKY | Device, external penile rigidity |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-10-17 |
| Device Publish Date | 2016-09-20 |
| 10067981957522 | Penile Rigidity Ring |
| 00067981957525 | Penile Rigidity Ring |