Duns Number:047684501
Device Description: High Density Lead Glass Dose Drawing Syringe Shield
Catalog Number
007-693
Brand Name
Dose Drawing Syringe Shield, 5/6 cc, with Replaceable Glass
Version/Model Number
007-693
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
IWR
Product Code Name
Holder, Syringe, Lead
Public Device Record Key
2d0d12b2-7665-451c-96d8-cd272df57be2
Public Version Date
July 19, 2022
Public Version Number
1
DI Record Publish Date
July 11, 2022
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 |