WellFine®

Primary DI
08809445832007
Brand
WellFine®
Company
MEDEXEL CO.,LTD.
Model
WellFine®Insulin Pen Needles 34Gx4mm 100pcs
Device description
Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm, and 12.7mm). Well Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic.Well Fine® Pen Needle assembly consists of hub, needle, needle cap, sterile cap and sterile paper.
Published
2019-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K152410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152410000Top Fine Pen NeedleMedexel Co.,Ltd2016-02-02FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809445832004PackageGS112In Commercial Distribution
28809445832001PackageGS16In Commercial Distribution
08809445832007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880944583200418809445832004
2880944583200128809445832001
08809445832007088094458320078809445832007

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Millimeter
Needle Gauge34Gauge

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+82312991077parkhj@medexel.co.kr

Regulatory Flags#

DUNS number
689719789
Device count
1
Lot or batch
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
08809445833622Topfine Insulin Syringe 31Gx5mm 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

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Primary DI, Brand, Company table
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