| Primary Device ID | 00850039704956 |
| NIH Device Record Key | ef87fc1c-91ee-4652-9390-d76e13c726cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OnX Tough 2 A1 Single-unit Capsule 3-Pack |
| Version Model Number | SRI-0204053 |
| Company DUNS | 063005260 |
| Company Name | Sprintray, Inc. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use OnX Tough 2 after the expiration date |
| Special Storage Condition, Specify | Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use OnX Tough 2 after the expiration date |
| Special Storage Condition, Specify | Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use OnX Tough 2 after the expiration date |
| Special Storage Condition, Specify | Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use OnX Tough 2 after the expiration date |
| Special Storage Condition, Specify | Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use OnX Tough 2 after the expiration date |