Duns Number:071595540
Device Description: THERMOGARD DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR
Catalog Number
CRA-SGP
Brand Name
ThermoGard
Version/Model Number
CRA-SGP
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
K140658,K140658,K140658
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
6983e18f-e223-48c0-8686-58aef039673d
Public Version Date
June 05, 2020
Public Version Number
2
DI Record Publish Date
April 15, 2020
Package DI Number
30653405986588
Quantity per Package
10
Contains DI Package
20653405986581
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 |