| Primary Device ID | 15032749040643 |
| NIH Device Record Key | 5f0370ff-e034-49b2-91e6-9fcbb00e80da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RAPONICEL™ |
| Version Model Number | ALGINATE PHMB |
| Catalog Number | 9040646 |
| Company DUNS | 770434090 |
| Company Name | ADVANCED MEDICAL SOLUTIONS LIMITED |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 |