Duns Number:481742760
Device Description: Sterile, single-use, safety pen needle, 31Gauge, 5mm (3/16”) Length
Catalog Number
700014895
Brand Name
Clickfine AutoProtect
Version/Model Number
700014895
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
369b6a2f-ca13-402e-a7a5-de7b90372040
Public Version Date
May 05, 2022
Public Version Number
1
DI Record Publish Date
April 27, 2022
Package DI Number
07613117026196
Quantity per Package
4500
Contains DI Package
07613117026264
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 |