| Primary Device ID | 05407005000199 |
| NIH Device Record Key | ca0f84b7-afca-439f-9a55-85cfdff71e6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spirotome Endo |
| Version Model Number | SS08EN |
| Catalog Number | SS08EN |
| Company DUNS | 371402316 |
| Company Name | Bioncise |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05407005000199 [Package] Contains: 05407005001196 Package: Box [5 Units] In Commercial Distribution |
| GS1 | 05407005001196 [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 | 2018-10-01 |
| Device Publish Date | 2018-08-31 |
| 05407005000229 | The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use |
| 05407005000212 | The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use |
| 05407005000205 | The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use |
| 05407005000199 | The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use |