Duns Number:315304071
Device Description: CUTTING ELECTRODE BIPO 24FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, inter CUTTING ELECTRODE BIPO 24FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 24/26, Fr, loop: round, wire Ø 0.3mm, fork color blue, stem color blue, PACK=3 PCS, for Shark and S-Line Resectoscopes, sterile, for single use
Catalog Number
4622.1313
Brand Name
SHARK/S-LINE
Version/Model Number
46221313
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
Yes
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
bf108e18-f85d-4631-b20c-3188daca09e2
Public Version Date
April 28, 2021
Public Version Number
7
DI Record Publish Date
June 28, 2017
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 |