Duns Number:043833813
Device Description: Shield, Vial, 5-30 ML, 0.12" Lead Equivalence High Density lead glass
Catalog Number
001-075
Brand Name
HIGH DENSITY LEAD GLASS VIAL SHIELD
Version/Model Number
001-075
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
3dce2b34-ae31-4cf3-9a6a-1e51a666d302
Public Version Date
April 18, 2019
Public Version Number
1
DI Record Publish Date
April 10, 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 | 193 |
2 | A medical device with a moderate to high risk that requires special controls. | 52 |