Duns Number:623214079
Device Description: G6PDH Control, Intermediate
Catalog Number
G5029
Brand Name
Trinity Biotech
Version/Model Number
G5029
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K802568
Product Code
KHG
Product Code Name
Whole Blood Hemoglobin Determination
Public Device Record Key
832fbf3a-f952-4131-b0a9-7477f5f0ab87
Public Version Date
November 06, 2019
Public Version Number
4
DI Record Publish Date
September 19, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 50 |
2 | A medical device with a moderate to high risk that requires special controls. | 116 |