FDA.reportPublic FDA data

3ml Suresafe Syringe

Primary DI
05391530750486
Brand
3ml Suresafe Syringe
Company
DMC MEDICAL LIMITED
Model
"3ml Syringe - 21G x 1"""
Catalog number
FD-SSIC03-21
Device description
"3ml Suresafe Automatic Retractable 21G x 1"" Syringe - Sterile"
Published
2016-08-12
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
K143497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143497000Safety Auto-Disable Syrine with Needle (Auto-Lock)Guangdong Intmed Medical Appliance Co., Ltd.2015-11-04MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530750493PackageGS1100In Commercial Distribution
05391530750509PackageGS110In Commercial Distribution
05391530750486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530750493053915307504935391530750493
05391530750509053915307505095391530750509
05391530750486053915307504865391530750486

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
05391530750035SVDS200 SAPHENOUS VEIN DISTENTION SYSTEM - 200mmHgSVDS200FD-10032016-08-10
05391530750066SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHgSVDS300FD-10042016-08-10
05391530750097Vein Irrigation Cannula DMC VIC SterileDMC VIC STERILEFD-10062016-08-10
05391530750127Cardiac Insulation Pad Adult Sterile Adult - SterileFD-10012016-08-11
053915307501581ml Insulin Suresafe Syringe"1ml Insulin Syringe - 29G x 1/2"""FD-SSFX01L-292016-08-11
053915307501891ml Tuberculin Suresafe Syringe"1ml Tuberculin Syringe - 27G x 1/2"""FD-SSFX01L-272016-08-11
053915307502191ml Tuberculin Suresafe Syringe"1ml Tuberculin Syringe - 25G x 5/8"""FD-SSFX01T-252016-08-11
053915307502401ml Tuberculin Suresafe Syringe"1ml Tuberculin Syringe - 25G x 1"""FD-SSFX01T-25-012016-08-11
05391530750271Suresafe 1ml Syringe"1ml Syringe - 25G x 5/8"""FD-SSFX01-252016-08-11
05391530750301Suresafe 1ml Syringe"1ml Syringe - 25G x 1"""FD-SSFX01-25-012016-08-11
053915307503323ml Suresafe Syringe"3ml Syringe - 25G x 5/8"""FD-SSIC03-252016-08-12
053915307503633ml Suresafe Syringe"3ml Syringe - 25G x 1"""FD-SSIC03-25-012016-08-12
053915307503943ml Suresafe Syringe"3ml Syringe - 23G x 1"""FD-SSIC03-232016-08-12
053915307504243ml Suresafe Syringe"3ml Syringe - 23G x 1 1/2"""FD-SSIC03-23-012016-08-12
053915307504553ml Suresafe Syringe"3ml Syringe - 22G x 1 1/2"""FD-SSIC03-222016-08-12
053915307505163ml Suresafe Syringe"3ml Syringe - 22G x 1"""FD-SSIC03-22-012016-08-12
053915307505473ml Suresafe Syringe"3ml Syringe - 21G x 1 1/2"""FD-SSIC03-21-012016-08-12
053915307505785ml Suresafe Syringe"5ml Syringe - 21G x 1 1/2"""FD-SSIC05-212016-08-12
053915307506085ml Suresafe Syringe"5ml Syringe - 22G x 1 1/2"""FD-SSIC05-222016-08-11
0539153075063910ml Suresafe Syringe"10ml Syringe - 22G x 1 1/2"""FD-SSIC10-222016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840330704868ProCureTwin Med, LLCMEG2026-05-27
10840330704875ProCureTwin Med, LLCMEG2026-05-27
10840330705544ProCureTwin Med, LLCMEG2026-05-27
10840330705551ProCureTwin Med, LLCMEG2026-05-27
10840330705568ProCureTwin Med, LLCMEG2026-05-27
08800052609204"SHINA SAFETY SYRINGE 1.0cc 23G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609211"SHINA SAFETY SYRINGE 1.0cc 25G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609228"SHINA SAFETY SYRINGE 3.0cc 23G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609235"SHINA SAFETY SYRINGE 3.0cc 25G x 1"""SHINA MED CORPORATIONMEG2026-03-25
09347144013093Metier MedicalMETIER MEDICAL LTDMEG2025-07-08
10850053289627SURGYCOSurgyco LLCMEG2024-08-09
10850053289634SURGYCOSurgyco LLCMEG2024-08-09
10850053289641SURGYCOSurgyco LLCMEG2024-08-09
10850053289665SURGYCOSurgyco LLCMEG2024-08-09
10885380184703MonojectCardinal Health 200, LLCMEG2024-03-26
10885380184987MonojectCardinal Health 200, LLCMEG2024-03-26
10885380184994MonojectCardinal Health 200, LLCMEG2024-03-26
10193489037869MedlineMEDLINE INDUSTRIES, INC.MEG2024-02-01
10612479268705McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
10612479268736McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
10193489037814MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037821MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037838MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037845MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037852MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037890MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037906MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037937MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037944MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037951MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10