| Primary Device ID | 00860003935866 |
| NIH Device Record Key | f3894c8f-3c20-438a-83fd-b287f5b2ded0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Praxis Medical CytoCore and CytoCore Luer Adapters |
| Version Model Number | C0025L |
| Company DUNS | 939493362 |
| Company Name | PRAXIS MEDICAL LLC |
| Device Count | 5 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003935835 [Unit of Use] |
| GS1 | 00860003935866 [Primary] |
| KNW | Instrument, Biopsy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-15 |
| Device Publish Date | 2022-06-07 |
| 00860003935866 - Praxis Medical CytoCore and CytoCore Luer Adapters | 2022-06-15CytoCore device (DI 00860003935804) with extra luer adapters pouch (DI 00860003935835) |
| 00860003935866 - Praxis Medical CytoCore and CytoCore Luer Adapters | 2022-06-15 CytoCore device (DI 00860003935804) with extra luer adapters pouch (DI 00860003935835) |
| 00860003935804 - Praxis Medical | 2020-08-17 The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft tissue for diagnostic sampling. It is eq |