Duns Number:140727624
Device Description: 10ml Vial Set
Catalog Number
ASPP99DPTVL
Brand Name
Vial Set
Version/Model Number
ASPP99DPTVL
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)
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
666b4fb6-054f-46d0-aea1-d9dcaf801b91
Public Version Date
July 27, 2022
Public Version Number
1
DI Record Publish Date
July 19, 2022
Package DI Number
20886333220988
Quantity per Package
40
Contains DI Package
00886333220984
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 347 |
2 | A medical device with a moderate to high risk that requires special controls. | 1205 |