Duns Number:689719789
Device Description: Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conj Top 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). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic.Top Fine® Pen Needle assembly consists of hub, needle, needle cap, sterile cap and sterile paper.
Catalog Number
-
Brand Name
TopFine®
Version/Model Number
TopFine®Insulin Pen Needles 32Gx4mm 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
a8594821-4a8c-4798-a6b2-9c7738d2bbf1
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
February 27, 2019
Package DI Number
28809445832094
Quantity per Package
6
Contains DI Package
18809445832097
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |