Duns Number:315304071
Device Description: HOOK ELECTRODE MONO 11.5FR 0° for ureteral resectoscope, electrode shape: hook, PACK=1 PC HOOK ELECTRODE MONO 11.5FR 0° for ureteral resectoscope, electrode shape: hook, PACK=1 PC, unsterile, reusable
Catalog Number
8724.921
Brand Name
NA
Version/Model Number
8724921
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
FAS
Product Code Name
ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Public Device Record Key
3a7a3f59-abef-48c7-920d-e19206a425ff
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 |