FDA.reportPublic FDA data

Safety Insulin Syringes

Primary DI
00616784690223
Brand
Safety Insulin Syringes
Company
Dynarex Corporation
Model
6902
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
K050131000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050131000INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGEM.K. Meditech Co. , Ltd.2005-04-05MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784690230PackageGS15In Commercial Distribution
00616784690223PrimaryGS10
00616784690216Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784690230006167846902306167846902300616784690230
00616784690223006167846902236167846902230616784690223
00616784690216006167846902166167846902160616784690216

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, safetyA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
100
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
00616784711720Disposable Ear Specula Tips For Diagnostic Otoscopes, Adult, 4.25 mm71172021-05-21
00616784418025Bandage Shears 7.5" (19.1 cm) Black41802020-11-08
00616784418124Bandage Shears 7.5" (19.1 cm) Blue41812020-11-08
00616784418223Bandage Shears 7.5" (19.1 cm) Magenta41822020-11-08
00616784418322Bandage Shears 7.5" (19.1 cm) Orange41832020-11-08
00616784418421Bandage Shears 7.5" (19.1 cm) Purple41842020-11-08
00616784418520Bandage Shears 7.5" (19.1 cm) Red41852020-11-08
00616784418629Bandage Shears 7.5" (19.1 cm) Teal41862020-11-08
00616784418728Bandage Shears 7.5" (19.1 cm) Yellow41872020-11-08
00616784419022Mini Scissors 4" (10.2 cm) Red41902020-11-08
00616784419121Bandage Shears 5.5" (14.0 cm) Black41912020-11-08
00616784419220Bandage Shears 5.5" (14.0 cm) Blue41922020-11-08
00616784419329Bandage Shears 5.5" (14.0 cm) Magenta41932020-11-08
00616784419428Bandage Shears, 5.5" (14.0 cm) Orange41942020-11-08
00616784419527Bandage Shears 5.5" (14.0 cm) Purple41952020-11-08
00616784419626Bandage Shears, 5.5" (14.0 cm) Red41962020-11-08
00616784419725Bandage Shears, 5.5" (14.0 cm) Teal41972020-11-08
00616784419824Bandage Shears,5.5" (14.0 cm) Yellow41982020-11-08
00616784711522PA SensiLance Pressure Activated Safety Lancets,Sterile71152021-05-21
00616784711621Disposable Ear Specula Tips, For Diagnostic Otoscopes, 2.5 mm, Pediatric71162021-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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