Duns Number:303639066
Device Description: Plastic Cannula HOLDEX® single-packed, sterile
Catalog Number
450216
Brand Name
Vacuette
Version/Model Number
450216
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)
Yes
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
FGY
Product Code Name
CANNULA, INJECTION
Public Device Record Key
781f90d0-3b22-4678-b067-0b9286f4fdbe
Public Version Date
October 13, 2020
Public Version Number
1
DI Record Publish Date
October 05, 2020
Package DI Number
39120017577509
Quantity per Package
1000
Contains DI Package
19120017577505
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |