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 ID: 18809445832004
• NIH Device Record Key: 11827e97-2943-42c0-93d1-32cbaebeeb4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WellFine®
• Version Model Number: WellFine®Insulin Pen Needles 34Gx4mm 100pcs
• Company DUNS: 689719789
• Company Name: MEDEXEL CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82312991077
• Email: parkhj@medexel.co.kr

Device Dimensions

• Needle Gauge: 34 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809445832007 [Primary]
GS1	18809445832004 [Package]; Contains: 08809445832007; Package: case [12 Units]; In Commercial Distribution
GS1	28809445832001 [Package]; Package: Master case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152410

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-02-23

On-Brand Devices [WellFine®]

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