| Primary Device ID | 08800016903621 |
| NIH Device Record Key | 89bafb4e-2980-48f6-a2e5-6e8371cf958b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fraxis DUO Set Package |
| Version Model Number | FRX-C2 |
| Company DUNS | 689842183 |
| Company Name | CLASSYS 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800016903621 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-07 |
| Device Publish Date | 2024-10-30 |
| 08800016903683 - Secret PRO Set Package | 2024-11-08 |
| 08800016903690 - Secret PRO Main Unit | 2024-11-08 |
| 08800016903706 - Secret PRO Articulated Arm | 2024-11-08 |
| 08800016903713 - Secret PRO Scanner Handpiece | 2024-11-08 |
| 08800016903720 - Secret PRO Needle Hanpdiece | 2024-11-08 |
| 08800016903737 - Secret PRO Bigger Handpiece | 2024-11-08 |
| 08800016903744 - Secret PRO Smartcure Handpiece | 2024-11-08 |
| 08800016903195 - Fraxis Duo 25Pin Needle Tip | 2024-11-07 |