Clickfine® pen needles 7809

GUDID 10857273002470

Clickfine pen needles are sterile, single-use medical devices intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide. Clickfine pen needles are used by healthcare professionals and lay users.

HTL STREFA S A

Autoinjector needle

• Primary Device ID: 10857273002470
• NIH Device Record Key: 3bce9a5d-bd6c-4e52-b9c7-ad5c88ca976a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clickfine® pen needles
• Version Model Number: 31G x 5 mm
• Catalog Number: 7809
• Company DUNS: 422528088
• Company Name: HTL STREFA S A
• Device Count: 100
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +48422700010
• Email: info@htl-strefa.pl
• Phone: +48422700010
• Email: info@htl-strefa.pl
• Phone: +48422700010
• Email: info@htl-strefa.pl
• Phone: +48422700010
• Email: info@htl-strefa.pl
• Phone: +48422700010
• Email: info@htl-strefa.pl
• Phone: +48422700010
• Email: info@htl-strefa.pl
• Phone: +48422700010
• Email: info@htl-strefa.pl
• Phone: +48422700010
• Email: info@htl-strefa.pl

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857273002473 [Primary]
GS1	10857273002470 [Package]; Contains: 00857273002473; Package: shipper [24 Units]; In Commercial Distribution
GS1	80857273002479 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171984

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-25
• Device Publish Date: 2026-02-17

On-Brand Devices [Clickfine® pen needles]

• 10857273002463: 33 pcs sterile, single use Clickfine pen needles per box, intended to be used with a pen injecto
• 10857273002555: Clickfine pen needles are sterile, single-use medical devices intended for use with pen injector
• 10857273002548: Clickfine pen needles are sterile, single-use medical devices intended for use with pen injector
• 10857273002487: Clickfine pen needles are sterile, single-use medical devices intended for use with pen injector
• 10857273002470: Clickfine pen needles are sterile, single-use medical devices intended for use with pen injector