Duns Number:315304071
Device Description: ROLLER ELECTRODE BIPO 21/24.5FR for hysteroscopy, for continuous irrigation sheaths, 21/ ROLLER ELECTRODE BIPO 21/24.5FR for hysteroscopy, for continuous irrigation sheaths, 21/ 24.5, Fr, electrode shape: roller, fork color transparent, stem color blue, PACK=3 PCS, for use in combination with the Princess resectoscope, sterile, for single use
Catalog Number
4653.023
Brand Name
PRINCESS
Version/Model Number
4653023
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
d04906dc-d412-4aa9-804c-8ba90bffec44
Public Version Date
April 21, 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 |