TopFine®

GUDID 18809445831830

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.

MEDEXEL CO.,LTD.

Hypodermic needle, single-use
Primary Device ID18809445831830
NIH Device Record Key5f046117-adf8-457b-904a-f522a3269bca
Commercial Distribution StatusIn Commercial Distribution
Brand NameTopFine®
Version Model NumberTopFine®Insulin Pen Needles 31Gx4mm 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+821044040469
Emailparkhj@medexel.co.kr

Device Dimensions

Needle Gauge31 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108809445831833 [Primary]
GS118809445831830 [Package]
Contains: 08809445831833
Package: case [12 Units]
In Commercial Distribution
GS128809445831837 [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 [TopFine®]

28809445832094Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti
18809445832073Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti
08809445831895Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti
18809445831885Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti
18809445831878Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti
18809445831854Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti
18809445831847Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti
18809445831830Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti
18809445831823Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti
18809445831816Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti
18809445831809Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti
18809445831793Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti
18809445831786Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti
18809445831779Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjuncti

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