Duns Number:203044268
Device Description: Sterile transrectal needle guide with sheath for use with the Exact Imaging EV29L Transduc Sterile transrectal needle guide with sheath for use with the Exact Imaging EV29L Transducer
Catalog Number
EV-29L-TRK-1
Brand Name
Sterile transrectal needle guide with sheath
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
-
Product Code
OIJ
Product Code Name
Biopsy Needle Guide Kit
Public Device Record Key
cfbc9ee1-8e91-4d59-8452-f878ddb77f63
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
February 03, 2021
Package DI Number
10628055481161
Quantity per Package
5
Contains DI Package
00628055481157
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 |