Duns Number:315304071
Device Description: CUTTING ELECTRODE BIPO 26FR 0° for resectoscopes, telescope Ø 4mm, for sheaths, intermitt CUTTING ELECTRODE BIPO 26FR 0° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent irrigation, 26, Fr, loop: round, wire Ø 0.3mm, fork color green, stem color blue, PACK=3 PCS, for Shark and S-Line Resectoscopes, sterile, for single use
Catalog Number
4611.0313
Brand Name
SHARK/S-LINE
Version/Model Number
46110313
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
JOS
Product Code Name
Electrode, electrosurgical
Public Device Record Key
2a961c7b-ed50-4a0f-a05e-447870e036d5
Public Version Date
May 10, 2019
Public Version Number
5
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 |