Clickfine® pen needles 9727

GUDID 10857273002463

33 pcs sterile, single use Clickfine pen needles per box, intended to be used with a pen injector devices for the subcutaneous injection of fluids, including insulin and exenatide.

HTL STREFA S A

Autoinjector needle

• Primary Device ID: 10857273002463
• NIH Device Record Key: 3692678b-0ed8-4533-bdb3-80fe168b9661
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clickfine® pen needles
• Version Model Number: 31G x 5 mm
• Catalog Number: 9727
• Company DUNS: 422528088
• Company Name: HTL STREFA S A
• Device Count: 33
• 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
• 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	00857273002466 [Primary]
GS1	10857273002463 [Package]; Contains: 00857273002466; Package: shipper [45 Units]; In Commercial Distribution
GS1	80857273002462 [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: 2025-12-24
• Device Publish Date: 2025-12-16

Devices Manufactured by HTL STREFA S A

• 10857273002463 - Clickfine® pen needles: 2025-12-2433 pcs sterile, single use Clickfine pen needles per box, intended to be used with a pen injector devices for the subcutaneous injection of fluids, including insulin and exenatide.
• 10857273002463 - Clickfine® pen needles: 2025-12-24 33 pcs sterile, single use Clickfine pen needles per box, intended to be used with a pen injector devices for the subcutaneous i
• 10857273002098 - droplet® pen needles: 2025-05-05 Sterile single use droplet® pen needles intended for use with pen injector devices for the subcutaneous injection of drugs.
• 10857273002210 - droplet® pen needles: 2025-05-05 Sterile single use droplet® pen needles intended for use with pen injector devices for the subcutaneous injection of drugs.
• 10857273002227 - droplet® pen needles: 2025-05-05 Sterile single use droplet® pen needles intended for use with pen injector devices for the subcutaneous injection of drugs.
• 80857273002233 - droplet® pen needles: 2025-05-05 Sterile single use droplet® pen needles intended for use with pen injector devices for the subcutaneous injection of drugs.
• 10857273002241 - droplet® pen needles: 2025-05-05 Sterile single use droplet® pen needles intended for use with pen injector devices for the subcutaneous injection of drugs.
• 10857273002258 - droplet® pen needles: 2025-05-05 Sterile single use droplet® pen needles intended for use with pen injector devices for the subcutaneous injection of drugs.
• 10857273002265 - droplet® pen needles: 2025-05-05 Sterile single use droplet® pen needles intended for use with pen injector devices for the subcutaneous injection of drugs.