Duns Number:965417181
Device Description: Stainless Steel Reusable Endocavity Needle Guide for Samsung Medison 3D5-8EK and 3D5-9EK U Stainless Steel Reusable Endocavity Needle Guide for Samsung Medison 3D5-8EK and 3D5-9EK Ultrasound Transducers
Catalog Number
-
Brand Name
Reusable Stainless Steel Endocavity Needle Guide
Version/Model Number
6190
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
-
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
1086f597-07f4-4d9a-a4cb-5ea9accdb794
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
September 16, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |