Duns Number:071595540
Device Description: ULTRACLEAN ACCESSORY ELECTRODE, 1" COATED BLADE WITH EXTENDED INSULATION
Catalog Number
139104EXTNSB
Brand Name
ULTRACLEAN
Version/Model Number
139104EXTNSB
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
-
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
d6449544-cc87-45b0-815b-95e6777398fa
Public Version Date
October 22, 2021
Public Version Number
1
DI Record Publish Date
October 14, 2021
Package DI Number
20653405036057
Quantity per Package
1
Contains DI Package
40653405036051
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 |