Duns Number:134614411
Device Description: Reusable non-sterile needle guide with cleaning brushes (5) for use with Siemens 9EVF4 and
Catalog Number
10031556
Brand Name
Needle Guide
Version/Model Number
10031556
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2020
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
K875240,K875240
Product Code
IYO
Product Code Name
System, imaging, pulsed echo, ultrasonic
Public Device Record Key
dfcb26c1-3f96-414f-ab17-9cf5546547f6
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
August 22, 2017
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 |
|---|---|---|
| 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 |