Sure Fine™ Insulin Syringes 0.3cc 30G 8mm

Primary DI
08800052608016
Brand
Sure Fine™ Insulin Syringes 0.3cc 30G 8mm
Company
SHINA MED CORPORATION
Model
SFI33081
Device description
Sure Fine™ Insulin Syringes 0.3cc 30G 8mm
Published
2023-11-07
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
K210848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210848000Sure-Fine Insulin SyringesShina Med Corporation2022-03-01FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800052607699PackageGS1100In Commercial Distribution
08800052607705PackageGS15In Commercial Distribution
08800052607712PackageGS16In Commercial Distribution
08800052608016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800052607699088000526076998800052607699
08800052607705088000526077058800052607705
08800052607712088000526077128800052607712
08800052608016088000526080168800052608016

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
10840330704868ProCureTwin Med, LLCFMF2026-05-27
10840330704875ProCureTwin Med, LLCFMF2026-05-27
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
08800052609501"Sure Fine Insulin Syringe 1.0cc 31G x 5/16"""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
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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