Duns Number:965417181
Device Description: Sterile Disposable Endocavity Needle Guide for use with Samsung Medison EC4-9, EC4-9/10ED, Sterile Disposable Endocavity Needle Guide for use with Samsung Medison EC4-9, EC4-9/10ED, EC4-9/10R, ER4-9, ER4-9/10ED, EV4-9, EV4-9/10ED & EVN4-9, Alpinion EC3-10 & EN3-10, Prosonic EC10R, Philips C9-4EC, and Ultrasonix EC9-5/10 Ultrasound Transducers
Catalog Number
5555
Brand Name
Sterile Disposable Endocavity Needle Guide
Version/Model Number
5555
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
97b45376-300f-4e52-9a07-5245bdfaa01f
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
June 01, 2020
Package DI Number
10841912106605
Quantity per Package
24
Contains DI Package
00841912106608
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 |