| Primary Device ID | 30009336010609 |
| NIH Device Record Key | 8480b8dc-354a-4c15-9089-511902fb2d26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nissha Medical Technologies |
| Version Model Number | O-5235-60 |
| Catalog Number | 4010425C |
| Company DUNS | 002111896 |
| Company Name | GRAPHIC CONTROLS ACQUISITION CORP |
| Device Count | 60 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Protect from light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Protect from light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Protect from light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Protect from light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Protect from light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Protect from light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Protect from light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Protect from light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Protect from light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Protect from light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Protect from light |