Duns Number:071426803
Device Description: 31 fine gauge 1/2" needle, high quality economical plastic hub hypodermic needles. Fits b 31 fine gauge 1/2" needle, high quality economical plastic hub hypodermic needles. Fits both luer slip and luer lock syringes, tri-beveled tip. Sterile
Catalog Number
-
Brand Name
ACU-NEEDLE
Version/Model Number
NP315
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
K874024,K874024
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
e41fe056-5b37-45b3-9b69-b75863b816f4
Public Version Date
January 13, 2020
Public Version Number
1
DI Record Publish Date
January 03, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 61 |