FDA.reportPublic FDA data

"Sure Fine Pen Needle 29G x 1/2"""

Primary DI
08800052609297
Brand
"Sure Fine Pen Needle 29G x 1/2"""
Company
SHINA MED CORPORATION
Model
SFP2912
Device description
"Sure Fine Pen Needle 29G x 1/2"""
Published
2026-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K250658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250658000SureFine Pen NeedleShina Med Corporation2025-04-03FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800052608450PackageGS1100In Commercial Distribution
08800052608467PackageGS112In Commercial Distribution
08800052608474PackageGS16In Commercial Distribution
08800052609297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800052608450088000526084508800052608450
08800052608467088000526084678800052608467
08800052608474088000526084748800052608474
08800052609297088000526092978800052609297

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
Ethylene Oxide

Regulatory Flags#

DUNS number
689061990
Device count
1
Lot or batch
true
Expiration date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800052609204"SHINA SAFETY SYRINGE 1.0cc 23G x 1"""WNLS01232026-03-25
08800052609211"SHINA SAFETY SYRINGE 1.0cc 25G x 1"""WNLS01252026-03-25
08800052609228"SHINA SAFETY SYRINGE 3.0cc 23G x 1"""WNLS03232026-03-25
08800052609235"SHINA SAFETY SYRINGE 3.0cc 25G x 1"""WNLS03252026-03-25
08800052609242Sure Fine Pen Needle 32G x 4mmSFP32042026-03-25
08800052609259Sure Fine Pen Needle 31G x 8mmSFP31082026-03-25
08800052609266Sure Fine Pen Needle 32G x 6mmSFP32062026-03-25
08800052609273"Sure Fine Pen Needle 30G x 5/16"""SFP30082026-03-25
08800052609280Sure Fine Pen Needle 31G 5mmSFP31052026-03-25
08800052609303"Sure Fine Insulin Syringe 0.3cc 31G x 1/4"""SFI331612026-03-25
08800052609310"Sure Fine Insulin Syringe 0.3cc 31G x 5/16"""SFI331812026-03-25
08800052609327"Sure Fine Insulin Syringe 0.3cc 30g x 5/16"""SFI330812026-03-25
08800052609334"Sure Fine Insulin Syringe 0.3cc 30G x 1/2"""SFI330112026-03-25
08800052609341"Sure Fine Insulin Syringe 0.5cc 31G x 5/16"""SFI531812026-03-25
08800052609358"Sure Fine Insulin Syringe 0.5cc 30G x 1/2"""SFI530112026-03-25
08800052609365"Sure Fine Insulin Syringe 0.5cc 30G x 5/16"""SFI530812026-03-25
08800052609372"Sure Fine Insulin Syringe 0.5cc 29G x 1/2"""SFI529112026-03-25
08800052609389"Sure Fine Insulin Syringe 1.0cc 31G x 5/16"""SFI131812026-03-25
08800052609396"Sure Fine Insulin Syringe 1.0cc 30g x 5/16"""SFI130812026-03-25
08800052609402"Sure Fine Insulin Syringe 1.0cc 30G x 1/2"""SFI130112026-03-25

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