Duns Number:688460539
Device Description: SG15G: Ground, EMG Surface Electrode, 40x48mm, Cloth, Hydrogel
Catalog Number
-
Brand Name
BIOPROTECH INC.
Version/Model Number
SG15G
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
K153019,K153019,K153019
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
f8d6ee15-7fae-487f-b33e-b3bac05904d7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 18, 2016
Package DI Number
28809083940991
Quantity per Package
10
Contains DI Package
18809083940994
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 53 |