Duns Number:134614411
Device Description: Reusable sterile transition wedge (1) with disposable needle guide tubes, (3.5 x 20cm) lat Reusable sterile transition wedge (1) with disposable needle guide tubes, (3.5 x 20cm) latex covers (20) for use with Philips C9-5 ICT transducer
Catalog Number
613-057
Brand Name
Needle Guide
Version/Model Number
613-057
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 15, 2021
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)
Yes
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
K970514,K970514
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
311cc172-4a56-468a-8397-65d8d006afcd
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
August 22, 2017
Package DI Number
00841436104890
Quantity per Package
10
Contains DI Package
10841436104897
Package Discontinue Date
March 15, 2021
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 443 |