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
b31a0c91-21ec-4395-a7cd-5cb25bca13c9
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
July 17, 2017
Package DI Number
20653405033254
Quantity per Package
50
Contains DI Package
40653405033258
Package Discontinue Date
-
Package Status
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 |