Duns Number:203044268
Device Description: The EV29L Sterile Biopsy Needle Guide is a specially designed biopsy needle guide for use The EV29L Sterile Biopsy Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer.
Catalog Number
EV-BIOG-1
Brand Name
Needle Guide for use with the Exact Imaging EV29L Transducer
Version/Model Number
Single Unit
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
Yes
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
K162972,K162972,K162972
Product Code
OIJ
Product Code Name
Biopsy Needle Guide Kit
Public Device Record Key
503840cf-7bbd-4099-8ec1-21b8d1a8866a
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
February 08, 2017
Package DI Number
20628055481076
Quantity per Package
24
Contains DI Package
00628055481058
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |