Duns Number:827221698
Device Description: Reliable Medical 2 x 2
Catalog Number
-
Brand Name
Reliable Medical
Version/Model Number
EF2020BC2-TU
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 13, 2018
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
-
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
94f03bc8-e940-45cc-9855-ed6b790d7f38
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
June 13, 2018
Package DI Number
40092237616916
Quantity per Package
8
Contains DI Package
50092237616913
Package Discontinue Date
June 13, 2018
Package Status
Not in Commercial Distribution
Package Type
master
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 62 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |
| U | Unclassified | 2 |