Duns Number:106793995
Device Description: ORGANON TEKNIKA: Test Trays, for use with the Coag-A-Mate XM analyzer, 100/Box, 10 Boxes/C ORGANON TEKNIKA: Test Trays, for use with the Coag-A-Mate XM analyzer, 100/Box, 10 Boxes/Case
Catalog Number
-
Brand Name
Globe Scientific
Version/Model Number
5112
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 17, 2021
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
LXG
Product Code Name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Public Device Record Key
f4ca2b1f-6ccc-4fa7-853b-5e4eb6732780
Public Version Date
November 18, 2021
Public Version Number
3
DI Record Publish Date
November 26, 2019
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 | 184 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |