"Sure Fine Insulin Syringe 1.0cc 31G x 5/16"""

Primary DI
08800052609501
Brand
"Sure Fine Insulin Syringe 1.0cc 31G x 5/16"""
Company
SHINA MED CORPORATION
Model
SFI13181
Device description
"Sure Fine Insulin Syringe 1.0cc 31G x 5/16"""
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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191531000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191531000Sure-Fine Insulin SyringesShina Med Corporation2019-09-06FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800052609082PackageGS110In Commercial Distribution
08800052609099PackageGS15In Commercial Distribution
08800052609105PackageGS16In Commercial Distribution
08800052609624PackageGS110In Commercial Distribution
08800052609501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800052609082088000526090828800052609082
08800052609099088000526090998800052609099
08800052609105088000526091058800052609105
08800052609624088000526096248800052609624
08800052609501088000526095018800052609501

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.

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
08800052609297"Sure Fine Pen Needle 29G x 1/2"""SFP29122026-03-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800052609303"Sure Fine Insulin Syringe 0.3cc 31G x 1/4"""SHINA MED CORPORATIONFMF2026-03-25
08800052609310"Sure Fine Insulin Syringe 0.3cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609327"Sure Fine Insulin Syringe 0.3cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609334"Sure Fine Insulin Syringe 0.3cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609341"Sure Fine Insulin Syringe 0.5cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609358"Sure Fine Insulin Syringe 0.5cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609365"Sure Fine Insulin Syringe 0.5cc 30G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609372"Sure Fine Insulin Syringe 0.5cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609389"Sure Fine Insulin Syringe 1.0cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609396"Sure Fine Insulin Syringe 1.0cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609402"Sure Fine Insulin Syringe 1.0cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609419"Sure Fine Insulin Syringe 1.0cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609426"Sure Fine Insulin Syringe 0.3cc 31G x 1/4"""SHINA MED CORPORATIONFMF2026-03-25
08800052609433"Sure Fine Insulin Syringe 0.3cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609440"Sure Fine Insulin Syringe 0.3cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609457"Sure Fine Insulin Syringe 0.3cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609464"Sure Fine Insulin Syringe 0.5cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609471"Sure Fine Insulin Syringe 0.5cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609488"Sure Fine Insulin Syringe 0.5cc 30G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609495"Sure Fine Insulin Syringe 0.5cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609518"Sure Fine Insulin Syringe 1.0cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609525"Sure Fine Insulin Syringe 1.0cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609532"Sure Fine Insulin Syringe 1.0cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08699207302028Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207305036Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207310030Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207311006Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207320022Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207350029Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08800109007038DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03