Duns Number:002348191
Device Description: Disposable IMA/ENT 3/4" Needle Electrode Sterile Electrosurgical Electrode
Catalog Number
809337
Brand Name
WECK
Version/Model Number
IPN029475
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)
Yes
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
59c66dc8-1b44-4c50-8ead-f2f5ad076999
Public Version Date
August 24, 2022
Public Version Number
4
DI Record Publish Date
July 01, 2019
Package DI Number
24026704646023
Quantity per Package
24
Contains DI Package
14026704646026
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |