| Primary Device ID | 00850019162400 |
| NIH Device Record Key | befc5457-4d82-4f4e-afd7-c7f73ae68e1e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pelashield PainGuard |
| Version Model Number | PSPG1515 |
| Company DUNS | 962084500 |
| Company Name | IMBED BIOSCIENCES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 | 888-472-9898 |
| cs@imbedbio.com | |
| Phone | 888-472-9898 |
| cs@imbedbio.com | |
| Phone | 888-472-9898 |
| cs@imbedbio.com | |
| Phone | 888-472-9898 |
| cs@imbedbio.com | |
| Phone | 888-472-9898 |
| cs@imbedbio.com | |
| Phone | 888-472-9898 |
| cs@imbedbio.com | |
| Phone | 888-472-9898 |
| cs@imbedbio.com | |
| Phone | 888-472-9898 |
| cs@imbedbio.com | |
| Phone | 888-472-9898 |
| cs@imbedbio.com | |
| Phone | 888-472-9898 |
| cs@imbedbio.com | |
| Phone | 888-472-9898 |
| cs@imbedbio.com | |
| Phone | 888-472-9898 |
| cs@imbedbio.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850019162400 [Primary] |
| FRO | Dressing, Wound, Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-29 |
| Device Publish Date | 2025-08-21 |
| 00850019162400 | Pelashield PainGuard, 15cm x 15cm |
| 00850019162394 | Pelashield PainGuard, 10cm x 23cm |