Duns Number:530148444
Catalog Number
-
Brand Name
IMPROVACUTER® Multi Sample Needle
Version/Model Number
22G × 1″
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K153388,K153388,K153388
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
eddd99d3-7d82-43c8-8140-d50e34897d1f
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
December 26, 2016
Package DI Number
46933395621227
Quantity per Package
40
Contains DI Package
16933395621226
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 32 |