| Primary Device ID | 00841912102587 |
| NIH Device Record Key | 1015cc7a-b4fc-40ed-a9bb-2066e774fb89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reusable (Short Style) Stainless Steel Endocavity Needle Guide |
| Version Model Number | 6383 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| 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 | 00841912102587 [Direct Marking] |
| GS1 | 10841912102584 [Primary] |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841912102587]
Moist Heat or Steam Sterilization
[00841912102587]
Moist Heat or Steam Sterilization
[00841912102587]
Moist Heat or Steam Sterilization
[00841912102587]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2016-09-16 |
| 00841912102600 | Stainless Steel Reusable Endocavity Needle Guide for Esaote EC123 & Philips E6509 Ultrasound Tra |
| 00841912102594 | Short Style Stainless Steel Reusable Endocavity Needle Guide for Hitachi EUP-V33, -V33W, -V53W & |
| 00841912102587 | Short Style Stainless Steel Reusable Endocavity Needle Guide for Hitachi EUP-V33, -V33W, -V53W & |