FDA.reportPublic FDA data

Droplet® insulin syringe

Primary DI
00859135002812
Brand
Droplet® insulin syringe
Company
HTL STREFA S A
Model
1ml, 29G x 12,7 mm
Catalog number
6231
Device description
droplet insulin syringes with fixed needles is a sterile single use syringe for the injection of U-100 insulin only
Published
2025-02-20
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

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201044000CHIRANA Insulin SyringesChirana T. Injecta2022-01-18FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859135002819PackageGS120In Commercial Distribution
00859135002812PrimaryGS10
80859135002818Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085913500281910859135002819
00859135002812008591350028128591350028120859135002812
8085913500281880859135002818

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

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
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

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