Duns Number:071595540
Device Description: ULTRACLEAN ACCESSORY ELECTRODE, 6 INCH COATED BLADE
Catalog Number
139107
Brand Name
ULTRACLEAN
Version/Model Number
139107
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
ae27f29a-ea7d-482a-84e0-5bc98a98b90e
Public Version Date
October 17, 2022
Public Version Number
3
DI Record Publish Date
July 14, 2017
Package DI Number
20653405007309
Quantity per Package
50
Contains DI Package
10653405007302
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 | 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 |