Duns Number:481742760
Device Description: Sterile, single-use, 6-bevel pen needles, 31 Gauge, 5mm (3/16") Length, Extra-thin wall
Catalog Number
700021542
Brand Name
Clickfine Pen Needles
Version/Model Number
700021542
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)
Yes
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
da9bcbe2-6e29-4716-8352-d3d872f40f24
Public Version Date
September 02, 2022
Public Version Number
1
DI Record Publish Date
August 25, 2022
Package DI Number
07613117032326
Quantity per Package
40
Contains DI Package
07613117032302
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SHIPPER BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |