Duns Number:173770868
Device Description: Extended Length Temp Pacing Wire
Catalog Number
-
Brand Name
Myo/Wire
Version/Model Number
030-005
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
K803086
Product Code
LDF
Product Code Name
Electrode, Pacemaker, Temporary
Public Device Record Key
6a26659d-501c-47b9-9f36-2d99e9a796b6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2015
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 |
---|---|---|
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 |