Duns Number:134614411
Device Description: Reusable non-sterile needle guide with cleaning brushes (5) for use with Siemens EV-8C4 an Reusable non-sterile needle guide with cleaning brushes (5) for use with Siemens EV-8C4 and EVC8 transducers
Catalog Number
08245962
Brand Name
Needle Guide
Version/Model Number
8245962
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 16, 2019
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
K875128,K875240,K875128,K875240
Product Code
IYO
Product Code Name
System, imaging, pulsed echo, ultrasonic
Public Device Record Key
8020eba0-42f0-46fb-9ace-0f3007fec001
Public Version Date
June 17, 2022
Public Version Number
9
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 |