| Primary Device ID | 00850070544269 |
| NIH Device Record Key | 0fe47f62-e7e5-4618-8f72-6160df0a89d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OnX Tough 2 A2 Single-unit Capsule |
| Version Model Number | SRI-0204059 |
| 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 |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850070544269 [Primary] |
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-20 |
| Device Publish Date | 2025-02-12 |
| 00850070544160 - Ceramic Crown A3 Single-unit Capsule | 2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed |
| 00850070544177 - Ceramic Crown C2 Single-unit Capsule | 2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed |
| 00850070544184 - Ceramic Crown D2 Single-unit Capsule | 2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed |
| 00850070544191 - Ceramic Crown A3 Single-unit Capsule 3-Pack | 2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed |
| 00850070544207 - Ceramic Crown C2 Single-unit Capsule 3-Pack | 2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed |
| 00850070544214 - Ceramic Crown D2 Single-unit Capsule 3-Pack | 2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed |
| 00850070544238 - Ceramic Crown D3 Single-unit Capsule | 2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed |
| 00850070544252 - Ceramic Crown D3 Single-unit Capsule 3-Pack | 2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed |