FDA.reportPublic FDA data

Clickfine® pen needles

Primary DI
00857273002480
Brand
Clickfine® pen needles
Company
HTL STREFA S A
Model
31G x 6 mm
Catalog number
9749
Device description
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.
Published
2026-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171984000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171984000Clickfine Pen Needle, Penfine Classic Pen NeedleYpsomed AG2017-10-11FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857273002487PackageGS124In Commercial Distribution
00857273002480PrimaryGS10
80857273002486Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085727300248710857273002487
00857273002480008572730024808572730024800857273002480
8085727300248680857273002486

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+48422700010info@htl-strefa.pl

Regulatory Flags#

DUNS number
422528088
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857273002602droplet® pen needles32Gx4mm96962026-07-05
05903999601775DropSafe, safety pen needles31G x 6mm84322022-09-28
05903999601782DropSafe, safety pen needles31G x 8mm84332022-09-28
05903999601799DropSafe, safety pen needles31G x 5mm87972022-09-28
00857273002992droplet® pen needles32G x 6mm 75202026-04-21
05907996093045droplet® pen needles29G x 12mm83082016-09-22
05907996093069droplet® pen needles31G x 5mm83102016-09-22
05907996093038droplet® pen needles29G x 10mm83072016-09-22
05907996093052droplet® pen needles31G x 8mm83092016-09-22
00857273002473Clickfine® pen needles31G x 5 mm78092026-02-17
00857273002541Clickfine® pen needles31G x 8 mm97282026-02-17
00857273002558Clickfine® pen needles32G x 4 mm97512026-02-17
10857273002470Clickfine® pen needles31G x 5 mm78092026-02-17
10857273002487Clickfine® pen needles31G x 6 mm97492026-02-17
10857273002548Clickfine® pen needles31G x 8 mm97282026-02-17
10857273002555Clickfine® pen needles32G x 4 mm97512026-02-17
05907996090327Droplet, Lancing Devicen/a90062019-11-01
05901549097535droplet ® personal lancet33G72062019-12-01
05901549097542droplet ® personal lancet33G72072019-12-01
05907506237037Medlance, safety lancet21G 2.4mm70022020-08-15

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Primary DI, Brand, Company table
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20192253036982MonojectCardinal Health 200, LLCFMI2026-07-09
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00857273002602droplet® pen needlesHTL STREFA S AFMI2026-07-05