FDA.report

droplet® pen needle

Primary DI
05907996092697
Brand
droplet® pen needle
Company
HTL STREFA S A
Model
32G x 4mm
Catalog number
8315
Device description
100 pcs sterile, single use droplet® pen needles per box, intended to be used with a pen injector device for the subcutaneous injection of insulin or drugs
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15907996092694PackageGS130In Commercial Distribution
05907996092697PrimaryGS10
85907996092693Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1590799609269415907996092694
05907996092697059079960926975907996092697
8590799609269385907996092693

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+48422700010info@htl-strefa.com

Regulatory Flags

DUNS number
422528088
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
10857273002463Clickfine® pen needles31G x 5 mm97272025-12-16
10857273002098droplet® pen needles32Gx4mm92152025-04-25
10857273002210droplet® pen needles29Gx12mm92072025-04-25
10857273002227droplet® pen needles29Gx10mm92082025-04-25
80857273002233droplet® pen needles31Gx8mm92092025-04-25
10857273002241droplet® pen needles31Gx6mm92102025-04-25
10857273002258droplet® pen needles31Gx5mm92112025-04-25
10857273002265droplet® pen needles32Gx8mm 92122025-04-25
10857273002272droplet® pen needles32Gx6mm 92132025-04-25
10857273002289droplet® pen needles32Gx5mm 92142025-04-25
10859135002550Droplet® insulin syringe0.3ml, 31G x 6mm62192025-02-20
10859135002574Droplet® insulin syringe0.5ml, 31 x 6mm62202025-02-20
10859135002598Droplet® insulin syringe 1ml, 31 x 6mm62212025-02-20
10859135002611Droplet® insulin syringe 1ml, 31G x 8 mm62222025-02-20
10859135002635Droplet® insulin syringe0.5ml, 31G x 8 mm62232025-02-20
10859135002659Droplet® insulin syringe0.3ml, 31G x 8 mm62242025-02-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850033131208RegenKit®-THT-1-URegenlab USA LLCFMI2026-03-23
40888277358455MEDLINEMEDLINE INDUSTRIES, INC.FMI2026-03-19
40888277358462MEDLINEMEDLINE INDUSTRIES, INC.FMI2026-03-19
10050428324070TRUEplusTRIVIDIA HEALTH, INC.FMI2026-03-17
16923033459243EZFINE THIN WALL HYPODERMIC NEEDLEZhejiang Kindly Medical Devices Co., Ltd.FMI2026-03-10
00850056748568FORWARD® Intraosseous Infusion BundleINTEGRATED MEDCRAFT LLCFMI2026-03-02
10850060997980CerosRhino Medical Supply IncFMI2026-02-23
08800062763736SHARP NEEDLES, DermiSyncYONG CHANG CorporationFMI2026-02-23
10857273002470Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
10857273002487Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
10857273002548Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
10857273002555Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
50192253037119MonojectCardinal Health 200, LLCFMI2026-02-17
20850083784052Comfort EZS.D.I. USA, INC.FMI2026-02-13
20850083784175Comfort EZS.D.I. USA, INC.FMI2026-02-13
04046955143184Omnican® fineB. Braun Melsungen AktiengesellschaftFMI2026-02-10
04046961013068Omnican® fineB. Braun Melsungen AktiengesellschaftFMI2026-02-10
50192253037010MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037058MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037096MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037164MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037171MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037218MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038154MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038161MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038178MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038185MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038192MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038208MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038215MonojectCardinal Health 200, LLCFMI2026-02-10