Duns Number:927071162
Device Description: SG15G-15 Ground Cloth Surface Electrode 1.5m - Single Pack
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
SG15G-15
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
K073360,K073360,K073360
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
db695483-dcd8-465d-8f72-360c78e6b2bb
Public Version Date
June 05, 2020
Public Version Number
3
DI Record Publish Date
May 24, 2018
Package DI Number
20817325022952
Quantity per Package
10
Contains DI Package
10817325022955
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |