Duns Number:315304071
Device Description: SCALPEL 11.5FR CERAMIC SEMICIRCULAR resectoscope for small children, telescope Ø 2.7 mm, SCALPEL 11.5FR CERAMIC SEMICIRCULAR resectoscope for small children, telescope Ø 2.7 mm, cutting position 6 O'clock, for cutting urethral strictures, reusable
Catalog Number
8677.961
Brand Name
NA
Version/Model Number
8677961
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
f84cd178-79de-4e86-965f-4b7890ac7cdc
Public Version Date
April 27, 2021
Public Version Number
5
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 |