Duns Number:079241502
Device Description: Safety Needle, 23G x 1"
Catalog Number
-
Brand Name
Doctors Choice
Version/Model Number
SN230106
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"
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
K191644,K191644,K191644
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
d847dd81-44ff-44fb-ada0-2d6eafe14d4e
Public Version Date
October 25, 2021
Public Version Number
2
DI Record Publish Date
March 25, 2021
Package DI Number
G018SN2301061
Quantity per Package
100
Contains DI Package
G018SN2301060
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |