Duns Number:071595540
Device Description: ULTRACLEAN ACCESSORY ELECTRODE, 1 INCH COATED NEEDLE WITH EXTENDED INSULATION
Catalog Number
139105EXT
Brand Name
ULTRACLEAN
Version/Model Number
139105EXT
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
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
3cc0c21f-32a8-4eb5-8243-f38888a9373d
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
30653405033251
Quantity per Package
50
Contains DI Package
10653405033257
Package Discontinue Date
July 14, 2017
Package Status
Not in Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |