Duns Number:315304071
Device Description: EVAP-ELECTRODE MONO 24FR 0° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent EVAP-ELECTRODE MONO 24FR 0° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 22/24/25.5/26/27/28, Fr, wing (flat loop profile), fork color green, stem color blue, PACK=1 PC, for E-Line resectoscope, unsterile, reusable
Catalog Number
8411.151
Brand Name
E-LINE
Version/Model Number
8411151
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
KNF
Product Code Name
COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)
Public Device Record Key
b0810a00-c6b3-402e-9328-36eafa36f6f3
Public Version Date
September 25, 2018
Public Version Number
3
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 |