FDA.reportPublic FDA data

Topfine Insulin Syringe

Primary DI
08809445833622
Brand
Topfine Insulin Syringe
Company
MEDEXEL CO.,LTD.
Model
31Gx5mm 1.0ml
Device description
Top Fine® insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulinsyringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalentinsulin syringes. The syringes are available in 0.3 mI/cc, 0.5 mI/cc and 1 mi/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic,and non pyrogenic, for single use only, disposable. Rx only. The devices operate on the principles of common piston syringes.
Published
2026-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063348000TOP FINE INSULIN SYRINGEDaejin Tech Medical Manufacturing Co., Ltd.2007-03-01FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809445833622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809445833622088094458336228809445833622

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Millimeter
Needle Gauge31Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
689719789
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809445833363Topfine Insulin Syringe 29Gx5mm 0.5ml2026-04-23
08809445833370Topfine Insulin Syringe 30Gx5mm 0.5ml2026-04-23
08809445833387Topfine Insulin Syringe 31Gx5mm 0.5ml2026-04-23
08809445833394Topfine Insulin Syringe 28Gx8mm 0.5ml2026-04-23
08809445833400Topfine Insulin Syringe 29Gx8mm 0.5ml2026-04-23
08809445833417Topfine Insulin Syringe 30Gx8mm 0.5ml2026-04-23
08809445833424Topfine Insulin Syringe 31Gx8mm 0.5ml2026-04-23
08809445833431Topfine Insulin Syringe 28Gx12.7mm 0.5ml2026-04-23
08809445833448Topfine Insulin Syringe 29Gx12.7mm 0.5ml2026-04-23
08809445833455Topfine Insulin Syringe 30Gx12.7mm 0.5ml2026-04-23
08809445833462Topfine Insulin Syringe 31Gx12.7mm 0.5ml2026-04-23
08809445833608Topfine Insulin Syringe 29Gx5mm 1.0ml2026-04-23
08809445833615Topfine Insulin Syringe 30Gx5mm 1.0ml2026-04-23
08809445833639Topfine Insulin Syringe 28Gx8mm 1.0ml2026-04-23
08809445833646Topfine Insulin Syringe 29Gx8mm 1.0ml2026-04-23
08809445833653Topfine Insulin Syringe 30Gx8mm 1.0ml2026-04-23
08809445833660Topfine Insulin Syringe 31Gx8mm 1.0ml2026-04-23
08809445833677Topfine Insulin Syringe 29Gx12.7mm 1.0ml2026-04-23
08809445833684Topfine Insulin Syringe 28Gx12.7mm 1.0ml2026-04-23
08809445833691Topfine Insulin Syringe 30Gx12.7mm 1.0ml2026-04-23

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Primary DI, Brand, Company table
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