| Primary Device ID | 00850004857045 |
| NIH Device Record Key | 54b12ecb-2c28-4650-b2d8-9005b497191f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EDP |
| Version Model Number | EDP-MOS |
| Catalog Number | EDP-MOS |
| Company DUNS | 127526064 |
| Company Name | REACH MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 901-861-6068 |
| info@reachmedical.com |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850004857045 [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 | 2020-01-08 |
| Device Publish Date | 2019-12-31 |
| 00850004857069 | External Penile Rigidity Device Manual and Battery Operated |
| 00850004857052 | External Penile Rigidity Device Battery Operated |
| 00850004857045 | External Penile Rigidity Device Manually Operated |
| 00850004857113 | Manual Penile Rigidity Device. |