Duns Number:096372255
Device Description: Electrode, Lletz
Catalog Number
-
Brand Name
DeRoyal
Version/Model Number
88-1559
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"
Yes
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
HGI
Product Code Name
ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
7447d149-b309-47e2-8177-155ab5a2c65d
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
September 12, 2016
Package DI Number
50749756600663
Quantity per Package
10
Contains DI Package
00749756600668
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7041 |
2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
U | Unclassified | 3 |