Duns Number:203044268
Device Description: Non-Sterile Reusable Transrectal Needle Guide for use with the Exact Imaging EV29L Transdu Non-Sterile Reusable Transrectal Needle Guide for use with the Exact Imaging EV29L Transducer
Catalog Number
EV-BIOG-R16
Brand Name
Non-Sterile Reusable Needle Guide - 16GA
Version/Model Number
EV-BIOG-R16
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OIJ
Product Code Name
Biopsy Needle Guide Kit
Public Device Record Key
6c6e1b82-2c30-4323-9a11-2e95a9389ae7
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
May 13, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |