WellFine®

GUDID 18809445832004

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.

MEDEXEL CO.,LTD.

Hypodermic needle, single-use
Primary Device ID18809445832004
NIH Device Record Key11827e97-2943-42c0-93d1-32cbaebeeb4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameWellFine®
Version Model NumberWellFine®Insulin Pen Needles 34Gx4mm 100pcs
Company DUNS689719789
Company NameMEDEXEL CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82312991077
Emailparkhj@medexel.co.kr

Device Dimensions

Needle Gauge34 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108809445832007 [Primary]
GS118809445832004 [Package]
Contains: 08809445832007
Package: case [12 Units]
In Commercial Distribution
GS128809445832001 [Package]
Package: Master case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2019-02-23

On-Brand Devices [WellFine®]

18809445832011Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct
18809445832004Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct
18809445831991Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct
18809445831984Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct
18809445831977Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct
18809445831960Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct
18809445831953Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct
18809445831946Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct
18809445831939Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct
18809445831922Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct
18809445831915Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct
18809445831908Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct

Trademark Results [WellFine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WELLFINE
WELLFINE
97708087 not registered Live/Pending
Shenzhen Hongjing Electronics Co., Ltd.
2022-12-07
WELLFINE
WELLFINE
90741618 not registered Live/Pending
Shenzhen Hongjing Electronics Co., Ltd.
2021-05-28
WELLFINE
WELLFINE
90741601 not registered Live/Pending
Shenzhen Hongjing Electronics Co., Ltd.
2021-05-28
WELLFINE
WELLFINE
90741535 not registered Live/Pending
Shenzhen Hongjing Electronics Co., Ltd.
2021-05-28

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