Duns Number:067486548
Device Description: Lectron III Chloride 10 Electrode Conductivity Gel: 2.5 Gallon
Catalog Number
36-5010-38
Brand Name
Pharmaceutical Innovations
Version/Model Number
Lectron III Chloride 10 Electrode Conductivity Gel
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GYB
Product Code Name
Media, Electroconductive
Public Device Record Key
efc77606-eaad-438c-92a1-9c3d56dc3400
Public Version Date
April 08, 2019
Public Version Number
1
DI Record Publish Date
March 29, 2019
Package DI Number
10300365010384
Quantity per Package
1
Contains DI Package
00300365010387
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
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. | 35 |