| Primary Device ID | 00628055481225 |
| NIH Device Record Key | caa6e306-ebf2-43db-8b87-55cec0d44f99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EV29L Non-Sterile Reusable PrecisionPoint Adapter |
| Version Model Number | EV-BIOGR-PP |
| Catalog Number | EV-BIOGR-PP |
| Company DUNS | 203044268 |
| Company Name | Exact Imaging 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 | 00628055481225 [Primary] |
| OIJ | Biopsy Needle Guide Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00628055481225]
Moist Heat or Steam Sterilization
[00628055481225]
Moist Heat or Steam Sterilization
[00628055481225]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-13 |
| Device Publish Date | 2025-05-05 |
| 00628055481225 - EV29L Non-Sterile Reusable PrecisionPoint Adapter | 2025-05-13The EV29L Non-Sterile Reusable PrecisionPoint Adapter is used with the EV29L High Resolution transrectal side fire transducer (UHR-TRUS) for the ExactVu™ high resolution micro-ultrasound system, and the Perineologic PrecisionPoint transperineal needle guide. The adapter shall allow the PrecisionPoint guide to be attached to the EV29L transducer for use with transperineal biopsy. |
| 00628055481225 - EV29L Non-Sterile Reusable PrecisionPoint Adapter | 2025-05-13 The EV29L Non-Sterile Reusable PrecisionPoint Adapter is used with the EV29L High Resolution transrectal side fire transducer (U |
| 00628055481140 - Non-Sterile Reusable Needle Guide - 16GA | 2022-05-23 Non-Sterile Reusable Transrectal Needle Guide for use with the Exact Imaging EV29L Transducer |
| 00628055481096 - EV5C Abdominal Transducer | 2021-02-11 EV5C is an abdominal end-fire transducer. |
| 10628055481116 - Sterile transperineal needle guide with sheath | 2021-02-11 Sterile transperineal needle guide with sheath for use with the EV29L transducer. |
| 10628055481161 - Sterile transrectal needle guide with sheath | 2021-02-11 Sterile transrectal needle guide with sheath for use with the Exact Imaging EV29L Transducer |
| 00628055481089 - Reusable Needle Guide for use with the Exact Imaging EV29L Transducer | 2019-12-23 The EV29L Reusable Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer. |
| 20628055481076 - Needle Guide for use with the Exact Imaging EV29L Transducer | 2019-10-07 The EV29L Sterile Biopsy Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer. |
| 00628055481010 - ExactVu High Resolution Micro-Ultrasound System | 2018-07-06 The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultras |