| Primary Device ID | 00850004857007 |
| NIH Device Record Key | a7500a4e-8fe1-4d6d-854d-348323bdf165 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Penile Adjustable Loop |
| Version Model Number | PAL-01 |
| Catalog Number | PAL-01 |
| Company DUNS | 127526064 |
| Company Name | REACH MEDICAL, 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 | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 901-861-6068 |
| info@reachmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850004857007 [Primary] |
| LKY | Device, External Penile Rigidity |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-08 |
| Device Publish Date | 2019-02-05 |
| 00850004857113 - EDP | 2024-01-26 Manual Penile Rigidity Device. |
| 00850004857106 - EDP MAXRC | 2024-01-05 Rechargeable Penile Rigidity Device. |
| 00850004857045 - EDP | 2020-01-08 External Penile Rigidity Device Manually Operated |
| 00850004857052 - EDP | 2020-01-08 External Penile Rigidity Device Battery Operated |
| 00850004857069 - EDP | 2020-01-08 External Penile Rigidity Device Manual and Battery Operated |
| 00850004857007 - Penile Adjustable Loop | 2019-03-08Adjustable penile constriction band that can be used with or without a vacuum erection device. |
| 00850004857007 - Penile Adjustable Loop | 2019-03-08 Adjustable penile constriction band that can be used with or without a vacuum erection device. |