Duns Number:071595540
Device Description: THERMOGARD PLUS ABC DUAL DISPERSIVE ELECTRODE
Catalog Number
7-382
Brand Name
THERMOGARD
Version/Model Number
7-382
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
K140658,K140658,K140658
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
78db9141-40b5-4d58-b073-5469eea2c8f7
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20653405013744
Quantity per Package
40
Contains DI Package
10653405013747
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 |