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, ED4-9, EVN4-9, EC4-9/10ED, EV4-9 & ER4-9, and Ultrasonix EC9-5/10 Ultrasound Transducers
Catalog Number
5159
Brand Name
Sterile Disposable Endocavity Needle Guide Kit
Version/Model Number
5159
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
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
c2f4205d-24ae-4f4f-9f4d-1173bd540aec
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
August 31, 2018
Package DI Number
10841912105806
Quantity per Package
24
Contains DI Package
00841912105809
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 |