Duns Number:481742760
Device Description: sterile, single-use, 6-bevel pen needles, 31Gauge, 8mm (5/16") length, extra thin wall
Catalog Number
700019927
Brand Name
Clickfine pen needles
Version/Model Number
700019927
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
da38f35d-e83d-4ff4-b8be-771985a49bd8
Public Version Date
November 09, 2021
Public Version Number
1
DI Record Publish Date
November 01, 2021
Package DI Number
07613117031305
Quantity per Package
20
Contains DI Package
07613117031282
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 |