| Primary Device ID | 10841912104373 |
| NIH Device Record Key | a7f0dce0-e24d-4ead-9af8-0e7018e78f99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Director XT Multi Gauge Needle Guide |
| Version Model Number | 4500 |
| Catalog Number | 4500 |
| Company DUNS | 965417181 |
| Company Name | PROTEK MEDICAL PRODUCTS, 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 | 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 | 00841912104376 [Primary] |
| GS1 | 10841912104373 [Package] Contains: 00841912104376 Package: [24 Units] In Commercial Distribution |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2016-09-16 |
| 10841912106049 - System Cover | 2024-07-25 |
| 10841912106490 - Sterile Protective Barrier Kit | 2024-07-25 |
| 10841912106506 - Sterile Protective Barrier Kit | 2024-07-25 |
| 10841912106513 - Sterile Protective Barrier Kit | 2024-07-25 |
| 10841912106520 - Sterile Protective Barrier Kit | 2024-07-25 |
| 00841912106691 - Reusable Biopsy Bracket | 2022-06-10 Reusable Biopsy Bracket for Mindray L12-4s, 7L4s, L14-6Ns, L14-6NE & L12-3E Ultrasound Transducers |
| 00841912106745 - Biopsy Starter Kit | 2022-06-10 Biopsy Starter Kit for Mindray L12-4s, 7L4s, L14-6Ns, L14-6NE & L12-3E Ultrasound Transducers |
| 10841912107107 - Sterile Disposable Endocavity Needle Guide | 2022-04-11 Sterile Disposable Endocavity Needle Guide for Ultrasound Transducers |