Duns Number:689719789
Device Description: Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in con Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm, and 12.7mm). Well Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic.Well Fine® Pen Needle assembly consists of hub, needle, needle cap, sterile cap and sterile paper.
Catalog Number
-
Brand Name
WellFine®
Version/Model Number
WellFine®Insulin Pen Needles 34Gx5mm 100pcs
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152410,K152410,K152410
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
0791fdd9-aad3-4f82-b5af-58ff3401f969
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
February 23, 2019
Package DI Number
18809445832011
Quantity per Package
12
Contains DI Package
08809445832014
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |