Duns Number:439770017
Device Description: F9017W Multifunction adaptors for connection of disposable and reusable electrodes F9017W Multifunction adaptors for connection of disposable and reusable electrodes with grabber, clip or tab to electrostimulation and ECG recording cables for devices equipped with 4mm spring loaded plugs.
Catalog Number
F9017W
Brand Name
NA
Version/Model Number
F9017W
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
-
Product Code
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
d13d3196-8119-4ec3-9625-8eaee6350029
Public Version Date
July 16, 2021
Public Version Number
1
DI Record Publish Date
July 08, 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. | 42 |