Duns Number:965417181
Device Description: Sterile Disposable Endocavity Needle Guide for use with Samsung EA2-11B Ultrasound Transdu Sterile Disposable Endocavity Needle Guide for use with Samsung EA2-11B Ultrasound Transducers
Catalog Number
5295
Brand Name
Sterile Disposable Endocavity Needle Guide
Version/Model Number
5295
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
K971115,K971722,K971115,K971722
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
03d44e06-25f2-467c-96ca-75712a3760fc
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
August 17, 2018
Package DI Number
10841912105721
Quantity per Package
24
Contains DI Package
00841912105724
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. | 451 |