Duns Number:797372554
Catalog Number
AH+2025-1M
Brand Name
NIPRO HYPODERMIC NEEDLE
Version/Model Number
AH+2025
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
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
bc550a6f-4a36-48d0-97b8-13c2a10c94c6
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
40383790001906
Quantity per Package
10
Contains DI Package
20383790001902
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 230 |