Duns Number:342243334
Device Description: Urethrotome cold-knife,straight 21Ch.
Catalog Number
37.015.21
Brand Name
Urethrotome cold-knife,straight 21Ch.
Version/Model Number
37.015.21
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FAS
Product Code Name
ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Public Device Record Key
b1345992-ff97-41d2-8189-58a23d98c19d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 03, 2016
Package DI Number
EMAH37015211
Quantity per Package
1
Contains DI Package
EMAH37015210
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 | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 1976 |