Duns Number:658637244
Catalog Number
-
Brand Name
RIGHTEST GT333 Blood Glucose Test Strip
Version/Model Number
25pcs
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
17a19ffd-23e7-43db-8f38-c4a0a9dbf24e
Public Version Date
October 16, 2019
Public Version Number
1
DI Record Publish Date
October 08, 2019
Package DI Number
20883489001874
Quantity per Package
12
Contains DI Package
10883489001877
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
paper
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 9 |
2 | A medical device with a moderate to high risk that requires special controls. | 11 |