| Primary Device ID | 00855638007040 |
| NIH Device Record Key | d6f48102-d9c7-40a5-bf4c-7e8453336fec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GlucanPro 3000 |
| Version Model Number | GPC3-0035 |
| Catalog Number | GPC3-0035 |
| Company DUNS | 801160037 |
| Company Name | STELLEN MEDICAL, LLC |
| 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 | false |
| 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 | true |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Total Volume | 3.5 Fluid Ounce |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855638007040 [Primary] |
| GS1 | 00855638007057 [Package] Package: Box [6 Units] In Commercial Distribution |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-30 |
| Device Publish Date | 2020-10-22 |
| 00855638007071 | GlucanPro Cream is intended to be used as an aid in the management of superficial abrasions, scr |
| 00855638007040 | GlucanPro Cream is intended to be used as an aid in the management of superficial abrasions, scr |