Duns Number:543063066
Catalog Number
-
Brand Name
Foot Switch
Version/Model Number
HRF-M52
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K210154
Product Code
IYN
Product Code Name
System, Imaging, Pulsed Doppler, Ultrasonic
Public Device Record Key
65b01d43-74c7-46b5-a951-2e178eddbb7e
Public Version Date
November 08, 2021
Public Version Number
1
DI Record Publish Date
October 31, 2021
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. | 75 |