Duns Number:082522269
Device Description: AccuRelief Universal Supply KIT
Catalog Number
-
Brand Name
AccuRelief
Version/Model Number
ACRL-0001
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
-
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
a387c6de-f8f7-4187-8259-324764bf6552
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
October 05, 2016
Package DI Number
30023601200014
Quantity per Package
6
Contains DI Package
00023601200013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 34 |