Duns Number:303639066
Device Description: VACUETTE® Multiple Use Drawing Needle 20G x 1" yellow, sterile, not made with natural rubb VACUETTE® Multiple Use Drawing Needle 20G x 1" yellow, sterile, not made with natural rubber latex 0.9 x 25 mm
Catalog Number
450073
Brand Name
Vacuette
Version/Model Number
450073
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"
Yes
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
K973620,K973620,K973620,K973620
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
5bb06ee1-f5cb-4d61-9874-6945d2f849bb
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
39120017570197
Quantity per Package
20
Contains DI Package
29120017570190
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 |