Duns Number:173770868
Device Description: Disposable Patient Cable with Universal Pin Adapter, 1 per pouch
Catalog Number
-
Brand Name
MYO/WIRE™ Disposable Patient Cable 2.0, Universal Pin Style
Version/Model Number
119-535
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
Yes
Prescription Use (Rx)
-
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
1286fb52-7bc9-478f-84ed-7ea446494045
Public Version Date
March 08, 2019
Public Version Number
1
DI Record Publish Date
February 05, 2019
Package DI Number
20841291105548
Quantity per Package
8
Contains DI Package
10841291105541
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 27 |
2 | A medical device with a moderate to high risk that requires special controls. | 621 |