| Primary Device ID | 00861680000427 |
| NIH Device Record Key | 4cd609b2-9161-4bcf-9887-d25a3e297e2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Renew Inserts |
| Version Model Number | FG715 |
| Catalog Number | FG715 |
| Company DUNS | 967228474 |
| Company Name | RENEW MEDICAL INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-888-987-2929 |
| ricky@renew-medical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861680000427 [Primary] |
| PBP | Rectal Insert |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-10-01 |
| 10867476000043 | 30 pack carton of individually packaged Renew large size Inserts |
| 10867476000036 | 30 pack carton of individually packaged Renew regular size Inserts |
| 10867476000029 | Starter Pack of 10 individually packaged Renew Inserts consisting of 5 regular size and 5 large |
| 00861680000427 | Starter Pack of 5 individually packaged Renew Inserts consisting of 3 regular size and 2 large |
| 00861680000410 | 30 pack carton of individually packaged Renew large size single shot Inserts |
| 00861680000403 | 30 pack carton of individually packaged Renew regular size single shot Inserts |