Duns Number:021717889
Device Description: Remote Control Cable
Catalog Number
M004SVGA500
Brand Name
Maestro™ Remote Control Cable -50'
Version/Model Number
M004SVGA500
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
P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003
Product Code
LPB
Product Code Name
Cardiac ablation percutaneous catheter
Public Device Record Key
29ed5f21-2971-4cbe-be15-dd57d8c4e362
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 | 536 |
2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
3 | A medical device with high risk that requires premarket approval | 1821 |
U | Unclassified | 35 |