Duns Number:607903382
Device Description: Resectoscope cutting loop. Compatible with Karl Storz #27050 series adult resectoscope.
Catalog Number
U316R
Brand Name
Greenwald Surgical Company, Inc.
Version/Model Number
24810-24
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)
Yes
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
f6c19798-8444-4032-8b69-369086785a9f
Public Version Date
February 07, 2019
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 | 186 |
2 | A medical device with a moderate to high risk that requires special controls. | 220 |