FDA.reportPublic FDA data

Suresafe 1ml Syringe

Primary DI
05391530750271
Brand
Suresafe 1ml Syringe
Company
DMC MEDICAL LIMITED
Model
"1ml Syringe - 25G x 5/8"""
Catalog number
FD-SSFX01-25
Device description
"Suresafe 1ml syringe - 25G x 5/8"" Automatic retractable syringe - Sterile"
Published
2016-08-11
Public version status
Update
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
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141349000Disposable sterile needle retractable safety syringeGuangdong Haiou Medical Apparatus Stock Co., Ltd.2015-04-10MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530750288PackageGS1100In Commercial Distribution
05391530750295PackageGS121In Commercial Distribution
05391530750271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530750288053915307502885391530750288
05391530750295053915307502955391530750295
05391530750271053915307502715391530750271

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringe/needleA sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device.

Regulatory Flags#

DUNS number
989772017
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391530753982polycarbonate syringesFD-1095NS - 1ml PC Syringe Dark Green Plunger 1ml FD-1095NS - 1ml PC Syringe Dark Green Plunger 1ml 2026-10-01
05391530753999polycarbonate syringesFD-1094NS - 1ml PC Syringe Light Green Plunger 1mlFD-1094NS - 1ml PC Syringe Light Green Plunger 1ml2026-10-01
05391530754408polycarbonate syringesFD-1076NS 10ml PC Syringe Light Blue Flush PrintFD-1076NS 10ml PC Syringe Light Blue Flush Print2026-10-01
05391530754439polycarbonate syringes10ml PC Syringe Light Blue Plunger Saline Print10ml PC Syringe Light Blue Plunger Saline Print2026-10-01
05391530754750polycarbonate syringesFD-1116NS 10ml PC Syringe White Plunger Nitro PrinFD-1116NS 10ml PC Syringe White Plunger Nitro Prin2026-10-01
05391530754798polycarbonate syringesFD-1120NS 10ml PC Syringe Light Green Plunger SaliFD-1120NS 10ml PC Syringe Light Green Plunger Sali2026-10-01
05391530755351polycarbonate syringesFD-1190NS 10ml Nugen Syringe Yellow Plunger Non-StFD-1190NS 10ml Nugen Syringe Yellow Plunger Non-St2026-10-01
05391530754033Polycarbonate SyringeFD-1098NS 3ml PC Syringe Dark Green PlungerFD-1098NS 3ml PC Syringe Dark Green Plunger2026-09-27
05391530754057Polycarbonate SyringeFD-1097NS 3ml PC Syringe Light Green PlungerFD-1097NS 3ml PC Syringe Light Green Plunger2026-09-27
05391530754118Polycarbonate SyringeFD-1068NS 3ml PC Syringe Red Plunger Nitro PrintFD-1068NS 3ml PC Syringe Red Plunger Nitro Print2026-09-27
05391530754149polycarbonate syringe6ml PC Syringe Light Green Plunger - Non-Sterile6ml PC Syringe Light Green Plunger - Non-Sterile2026-09-27
05391530754170polycarbonate syringeFD-1099NS 6ml PC Syringe Yellow PlungerFD-1099NS 6ml PC Syringe Yellow Plunger2026-09-27
05391530754255polycarbonate syringeFD-1105NS 20ml PC Syringe with Dark Green PlungerFD-1105NS 20ml PC Syringe with Dark Green Plunger2026-09-27
05391530754279polycarbonate syringe20ml PC Syringe Light Blue Plunger HEPARIN/SALINE 20ml PC Syringe Light Blue Plunger HEPARIN/SALINE 2026-09-27
05391530754286polycarbonate syringeFD-1104NS 20ml PC Syringe with Light Green PlungerFD-1104NS 20ml PC Syringe with Light Green Plunger2026-09-27
05391530754323polycarbonate syringe30ml PC Syringe White Plunger30ml PC Syringe White Plunger2026-09-27
05391530754385polycarbonate syringesFD-1079NS 10ml PC Syringe Purple Plunger Heparin PFD-1079NS 10ml PC Syringe Purple Plunger Heparin P2026-09-27
05391530754415polycarbonate syringeFD-1037NS 10ml PC Syringe Light Blue Plunger HeparFD-1037NS 10ml PC Syringe Light Blue Plunger Hepar2026-09-27
05391530754477polycarbonate syringeFD-1041NS 10ml PC Syringe Light Green Plunger HepaFD-1041NS 10ml PC Syringe Light Green Plunger Hepa2026-09-27
05391530754484polycarbonate syringe10ml PC Syringe Light Green Plunger Lidocaine Prin10ml PC Syringe Light Green Plunger Lidocaine Prin2026-09-27

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