| Primary Device ID | 17290019120091 |
| NIH Device Record Key | f709ea5b-980a-49df-b127-d4174e846a26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PathKeeper System |
| Version Model Number | TPL0001-01 |
| Company DUNS | 532374343 |
| Company Name | PATHKEEPER SURGICAL LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 07290019120094 [Primary] |
| GS1 | 17290019120091 [Package] Contains: 07290019120094 Package: [1 Units] In Commercial Distribution |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-01 |
| Device Publish Date | 2023-04-23 |
| 07290019120261 - S3D OTI Camera | 2024-03-20 |
| 17290019120336 - PathKeeper Surgical Accessories Kit | 2024-03-20 |
| 17290019120343 - PKS Patient Reference DRF | 2024-03-20 |
| 17290019120350 - PKS DRF 2 - ID 5.9 | 2024-03-20 |
| 17290019120367 - PKS DRF 4 - ID 7.9 | 2024-03-20 |
| 17290019120374 - PKS DRF 3 - ID 12.2 | 2024-03-20 |
| 17290019120183 - PKS Accessories Setup DRF | 2023-11-28 |
| 17290019120206 - PKS Patient Reference DRF | 2023-11-28 |