WellFine® - Well Fine® Pen Needles are single use, sterile, - MEDEXEL CO.,LTD.

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.

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More Product Details

Catalog Number

-

Brand Name

WellFine®

Version/Model Number

WellFine®Insulin Pen Needles 34Gx4mm 100pcs

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

11827e97-2943-42c0-93d1-32cbaebeeb4d

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

February 23, 2019

Additional Identifiers

Package DI Number

18809445832004

Quantity per Package

12

Contains DI Package

08809445832007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"MEDEXEL CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3