FDA.reportPublic FDA data

droplet® pen needles

Primary DI
15907996092991
Brand
droplet® pen needles
Company
HTL STREFA S A
Model
32G x 8 mm
Catalog number
7869
Device description
90 pcs sterile, single use droplet® pen needles per box, intended to be used with a pen injector device for the subcutaneous injection of drugs.
Published
2019-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
K171982000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171982000DROPLET PEN NEEDLEHtl-Strefa S.A2018-03-21FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15907996092991PackageGS130In Commercial Distribution
05907996092994PrimaryGS10
85907996092990Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1590799609299115907996092991
05907996092994059079960929945907996092994
8590799609299085907996092990

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
422528088
Device count
90
DM exempt
false
Premarket exempt
false
HCT/P
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00857273002480Clickfine® pen needles31G x 6 mm97492026-02-17
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
Primary DIBrandCompanyProduct codePublished
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08056999020323SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020330SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020347SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020354SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27