Duns Number:173770868
Device Description: MYO/Wire® Ultra-Thin Quadpolar - 250cm - White/Blue - Flare/Hook 8/10mm electrode
Catalog Number
-
Brand Name
MYO/Wire® Ultra-Thin Temporary Pacing Wires
Version/Model Number
QEF2508AWB2D
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
K033858,K033858
Product Code
LDF
Product Code Name
ELECTRODE, PACEMAKER, TEMPORARY
Public Device Record Key
6f4fa27c-dfbf-45cb-8758-35ec6d14284e
Public Version Date
February 04, 2019
Public Version Number
5
DI Record Publish Date
November 11, 2015
Package DI Number
08718627412329
Quantity per Package
10
Contains DI Package
08718627412312
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 |