Duns Number:827221698
Device Description: IF 4K Lead Wires, one pair
Catalog Number
-
Brand Name
N/A
Version/Model Number
WW4488
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)
-
Over the Counter (OTC)
Yes
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
827fa880-92b8-4efa-91be-6ee80ad5fc16
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 13, 2016
Package DI Number
80092237617447
Quantity per Package
500
Contains DI Package
00092237617441
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 62 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |
| U | Unclassified | 2 |