Duns Number:607903382
Device Description: Teflon insulation. Tungsten alloy cutting wire. Resectoscope Cutting Loop. Compatible with Teflon insulation. Tungsten alloy cutting wire. Resectoscope Cutting Loop. Compatible with ACMI USA/Elite adult resectoscopes.
Catalog Number
U434RS
Brand Name
Greenwald Surgical Company, Inc.
Version/Model Number
33600-12
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)
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
b1117ed5-2e17-45ba-b3df-5bd88e731b5f
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10801334013691
Quantity per Package
6
Contains DI Package
10801334013042
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Dispenser Box
| 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 |