Duns Number:203044268
Device Description: The EV29L Reusable Needle Guide is a specially designed biopsy needle guide for use with t The EV29L Reusable Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer.
Catalog Number
EV-BIOGR
Brand Name
Reusable 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
-
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
K180636
Product Code
OIJ
Product Code Name
Biopsy Needle Guide Kit
Public Device Record Key
0fb14a12-76bf-4f55-b606-f02a0e3ef486
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
June 01, 2018
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 |