Sure Fine™ Insulin Syringes 1.0cc 29G 12.7mm

Primary DI
08800052607484
Brand
Sure Fine™ Insulin Syringes 1.0cc 29G 12.7mm
Company
SHINA MED CORPORATION
Model
SFI12911
Device description
Sure Fine™ Insulin Syringes 1.0cc 29G 12.7mm
Published
2023-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
08800052607484PackageGS1100In Commercial Distribution
08800052607491PackageGS15In Commercial Distribution
08800052607507PackageGS16In Commercial Distribution
08800052607941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800052607484088000526074848800052607484
08800052607491088000526074918800052607491
08800052607507088000526075078800052607507
08800052607941088000526079418800052607941

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
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

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