Duns Number:047684501
Device Description: T-Vial Shield
Catalog Number
0665-0002
Brand Name
Capintec T-Vial Shield
Version/Model Number
T-Vial Shield
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
-
Product Code
IWW
Product Code Name
Shield, Vial
Public Device Record Key
39d8d0b6-835f-4743-baec-1bd17b5035ae
Public Version Date
December 31, 2018
Public Version Number
1
DI Record Publish Date
November 28, 2018
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 | 81 |
2 | A medical device with a moderate to high risk that requires special controls. | 17 |