| Primary Device ID | 10841912100986 |
| NIH Device Record Key | e087cd49-a2b4-4568-a9ae-9dc3e9998a9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Director Sterile Disposable Needle Guide |
| Version Model Number | 4016 |
| Catalog Number | 4016 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841912100989 [Primary] |
| GS1 | 10841912100986 [Package] Contains: 00841912100989 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 |
| 10841912104502 | 4016/TL |
| 10841912101082 | 4025 |
| 10841912101075 | 4023 |
| 00841912101061 | 4022/TL |
| 10841912101051 | 4022 |
| 10841912101044 | 4021 |
| 10841912101020 | 4019 |
| 00841912101016 | 4018/TL |
| 10841912101006 | 4018 |
| 10841912100986 | 4016 |
| 00841912100972 | 4015/TL |
| 10841912100962 | 4015 |
| 10841912100955 | 4014 |
| 00841912100941 | 4013/TL |
| 10841912100931 | 4013 |