Duns Number:315304071
Device Description: SCALPEL 11.5FR HOOK-SHAPED for ureter resectoscope, cutting position 6 O'clock, for cutti SCALPEL 11.5FR HOOK-SHAPED for ureter resectoscope, cutting position 6 O'clock, for cutting strictures, reusable
Catalog Number
8724.981
Brand Name
NA
Version/Model Number
8724981
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EZO
Product Code Name
Urethrotome
Public Device Record Key
f90cdecf-f6c9-430d-abb5-5cc5b8f0ce5a
Public Version Date
September 21, 2018
Public Version Number
4
DI Record Publish Date
September 23, 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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |