Duns Number:965417181
Device Description: Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion EC3-10 & EN-10, Phili Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion EC3-10 & EN-10, Philips C9-4EC, Prosonic EC10R, Samsung Medison EV4-9/10ED, ER4-9/10ED, EC4-9, EVN4-9, EC4-9/10ED, EV4-9 & ER4-9, and Ultrasonix EC9-5/10 Ultrasound Transducers
Catalog Number
5183
Brand Name
Sterile Disposable Endocavity Needle Guide Kit
Version/Model Number
5183
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
K970893,K971115,K971722,K970893,K971115,K971722
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
ba6b7e88-764e-4c55-96fd-4b8a97099843
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
October 05, 2018
Package DI Number
10841912105844
Quantity per Package
24
Contains DI Package
00841912105847
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 |