Duns Number:094651270
Device Description: Disposable Electrosurgical Electrode, 4cm Long with 10mm Long 45 Degree Tip
Catalog Number
DN-0445
Brand Name
OptiMicro
Version/Model Number
Needle Electrode, 4cm
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K951032,K905263,K905263,K951032,K951032,K905263
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
76a584c2-c1b9-466c-8981-15be5fbd6f34
Public Version Date
December 18, 2019
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
H671DN04452
Quantity per Package
20
Contains DI Package
H671DN04451
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Overpack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |