Duns Number:303639066
Device Description: HOLDEX® Single-Use Holder PP single-packed, sterile, with lid on the inner packaging
Catalog Number
450263D
Brand Name
Vacuette
Version/Model Number
450263D
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
K980768,K980768,K980768
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
b42a920f-336d-4196-9e93-84865a3c7d0f
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
39120017577585
Quantity per Package
8
Contains DI Package
29120017577588
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 |