FDA.reportPublic FDA data

Securegard

Primary DI
05999039508012
Brand
Securegard
Company
SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
Model
1.0
Catalog number
5318D
Device description
"Securegard 1 ml 25Gx5/8"" syringe"
Published
2016-09-24
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
K993609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993609000SOLOGUARD LOCKING PLUS SYRINGESafeguard Medical Products, Inc.2000-03-17MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
5999039500160PackageGS1100In Commercial Distribution
5999039500177PackageGS110In Commercial Distribution
05999039508012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5999039500160059990395001605999039500160
5999039500177059990395001775999039500177
05999039508012059990395080125999039508012

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
401217526
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05999039514464Securegard1.05448E2023-09-28
05999039514471Securegard1.05448E2023-09-28
05999039511982Securegard1.05418R2023-06-22
05999039511999Securegard1.05418R2023-06-22
05999039507961Securegard1.05311I2016-09-24
05999039507985Securegard1.05311J2016-09-24
05999039507992Securegard1.05318B2016-09-24
05999039508418Securegard1.05348D2016-09-24
05999039508425Securegard1.05348E2016-09-24
05999039508432Securegard1.05348F2016-09-24
05999039508449Securegard1.05348G2016-09-24
05999039508456Securegard1.05348H2016-09-24
05999039508579Securegard1.05158E2016-09-24
05999039508586Securegard1.05158F2016-09-24
05999039508593Securegard1.05158G2016-09-24
05999039510619Securegard1.05158M2016-09-24
05999039512095Securegard1.05318R2016-09-24
05999039512132Securegard1.05311W2016-09-24
05999039512217Securegard1.05348R2016-09-24
05999039512293Securegard1.05348Q2016-09-24

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