Duns Number:303639066
Device Description: VACUETTE® Multiple Use Drawing Needle 21G x 1 1/4" green, sterile, not made with natural r VACUETTE® Multiple Use Drawing Needle 21G x 1 1/4" green, sterile, not made with natural rubber latex 0.8 x 32 mm
Catalog Number
450062
Brand Name
Vacuette
Version/Model Number
450062
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
3a0215e2-819d-4643-addd-00df201058c7
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
July 10, 2018
Package DI Number
39120049205012
Quantity per Package
20
Contains DI Package
29120049205015
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 |