Duns Number:118793157
Device Description: UDI TEST SKU Device Description
Catalog Number
-
Brand Name
UDI TEST SKU
Version/Model Number
A40401 TST
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 05, 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
FMH
Product Code Name
CONTAINER, SPECIMEN, STERILE
Public Device Record Key
6e54e902-9bd0-434e-9052-bee92c790b68
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 02, 2018
Package DI Number
37503025060232
Quantity per Package
100
Contains DI Package
17503025060238
Package Discontinue Date
June 05, 2018
Package Status
Not in Commercial Distribution
Package Type
PACKAGE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 634 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| 3 | A medical device with high risk that requires premarket approval | 12 |