| Primary Device ID | 00070942007276 |
| NIH Device Record Key | 802afca4-f66f-4a3f-99a1-6c90b99cc3bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GUM |
| Version Model Number | 9935 |
| Catalog Number | RA |
| Company DUNS | 025066358 |
| Company Name | SUNSTAR AMERICAS, INC. |
| Device Count | 36 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |