Duns Number:556115970
Device Description: NEEDLE,25 X 5/8
Catalog Number
-
Brand Name
AHS
Version/Model Number
AHS2516RN
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
5c1de816-c907-4300-872e-dc257b83d4cb
Public Version Date
November 09, 2020
Public Version Number
6
DI Record Publish Date
March 31, 2016
Package DI Number
B031AHS2516RN2
Quantity per Package
10000
Contains DI Package
B031AHS2516RN1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 62 |