FDA.reportPublic FDA data

Metered-delivery hypodermic syringe/needle

Definition
A 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.
GUDID devices
454
Last updated
2026-08-28 10:21:06

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00015482102913ASSURE® ID Insulin 1cc Safety SyringeArkray USA, Inc.2102912016-09-23
00015482102951ASSURE® ID Insulin 0.5cc Safety SyringeArkray USA, Inc.2102952016-09-23
00015482253110Assure® ID INSULIN SAFETY SYRINGE 1mL 31G x 6mmArkray USA, Inc.2533112020-05-26
00015482253158Assure® ID INSULIN SAFETY SYRINGE 0.5mL 31G x 6mmArkray USA, Inc.2533152020-05-26
00015482502911ASSURE® ID Safety Syringe 1mL 29G x 1/2"Arkray USA, Inc.2502912017-04-10
00015482502935ASSURE® ID INSULIN SAFETY SYRINGE .3mL 29G x 1/2"Arkray USA, Inc.2502932017-10-23
00015482502959ASSURE® ID Safety Syringe .5mL 29G x 1/2"Arkray USA, Inc.2502952017-04-10
00015482503116ASSURE® ID INSULIN SAFETY SYRINGE 1mL 31G x 5/16"Arkray USA, Inc.2503112017-10-23
00015482503130ASSURE® ID INSULIN SAFETY SYRINGE .3mL 31G x 5/16"Arkray USA, Inc.2503132017-10-23
00015482503154ASSURE® ID INSULIN SAFETY SYRINGE .5mL 31G x 5/16"Arkray USA, Inc.2503152017-10-23
00015482512514ASSURE® ID TB SAFETY SYRINGE 1mL 25G x 1"Arkray USA, Inc.2512512017-10-23
00015482512521ASSURE® ID TB SAFETY SYRINGE 1mL 25G x 5/8"Arkray USA, Inc.2512522017-08-30
00015482512736ASSURE® ID TB SAFETY SYRINGE 1mL 27G x 1/2"Arkray USA, Inc.2512732017-08-30
00015482512859ASSURE® ID TB SAFETY SYRINGE 1mL 28G x 1/2"Arkray USA, Inc.2512852017-08-30
00015482513160ASSURE® ID TB SAFETY SYRINGE 1mL 31G x 5/16"Arkray USA, Inc.2513162017-10-23
20884521014159MonojectCardinal Health, Inc.88815161352016-10-13
00304040017173Henry ScheinHENRY SCHEIN, INC.90076612016-09-24
00304040017180Henry ScheinHENRY SCHEIN, INC.90076622016-09-24
00613703101303VanishPoint®RETRACTABLE TECHNOLOGIES, INC.101312016-09-22
00613703101334VanishPoint®RETRACTABLE TECHNOLOGIES, INC.101342016-09-22
00613703101402VanishPoint®RETRACTABLE TECHNOLOGIES, INC.101412025-06-08
00613703101501VanishPoint®RETRACTABLE TECHNOLOGIES, INC.101512016-09-22
00613703101532VanishPoint®RETRACTABLE TECHNOLOGIES, INC.101542025-10-16
00613703101600VanishPoint®RETRACTABLE TECHNOLOGIES, INC.101612016-09-22
00613703101709VanishPoint®RETRACTABLE TECHNOLOGIES, INC.101712016-09-22
00613703102102VanishPoint®RETRACTABLE TECHNOLOGIES, INC.102112016-09-22
00613703102300VanishPoint®RETRACTABLE TECHNOLOGIES, INC.102312016-09-22
00613703102508VanishPoint®RETRACTABLE TECHNOLOGIES, INC.102512016-09-22
00613703102706VanishPoint®RETRACTABLE TECHNOLOGIES, INC.102712016-09-22
00613703102805VanishPoint®RETRACTABLE TECHNOLOGIES, INC.102812016-09-22
00613703102904VanishPoint®RETRACTABLE TECHNOLOGIES, INC.102912016-09-22
00613703103000VanishPoint®RETRACTABLE TECHNOLOGIES, INC.103012016-09-22
00613703103109VanishPoint®RETRACTABLE TECHNOLOGIES, INC.103112016-09-22
00613703103208VanishPoint®RETRACTABLE TECHNOLOGIES, INC.103212016-09-22
00613703103307VanishPoint®RETRACTABLE TECHNOLOGIES, INC.103312016-09-22
00613703103406VanishPoint®RETRACTABLE TECHNOLOGIES, INC.103412016-09-22
00613703103505VanishPoint®RETRACTABLE TECHNOLOGIES, INC.103512016-09-22
00613703103604VanishPoint®RETRACTABLE TECHNOLOGIES, INC.103612016-09-22
00613703103703VanishPoint®RETRACTABLE TECHNOLOGIES, INC.103712016-09-22
00613703103802VanishPoint®RETRACTABLE TECHNOLOGIES, INC.103812016-09-22
00613703103901VanishPoint®RETRACTABLE TECHNOLOGIES, INC.103912016-09-22
00613703104304VanishPoint®RETRACTABLE TECHNOLOGIES, INC.104312016-09-22
00613703105103VanishPoint®RETRACTABLE TECHNOLOGIES, INC.105112016-09-22
00613703105202VanishPoint®RETRACTABLE TECHNOLOGIES, INC.105212016-09-22
00613703105301VanishPoint®RETRACTABLE TECHNOLOGIES, INC.105312016-09-22
00613703105400VanishPoint®RETRACTABLE TECHNOLOGIES, INC.105412016-09-22
00613703105509VanishPoint®RETRACTABLE TECHNOLOGIES, INC.105512016-09-22
00613703105608VanishPoint®RETRACTABLE TECHNOLOGIES, INC.105612016-09-22
00613703105707VanishPoint®RETRACTABLE TECHNOLOGIES, INC.105712016-09-22
00613703105806VanishPoint®RETRACTABLE TECHNOLOGIES, INC.105812016-09-22
00613703105905VanishPoint®RETRACTABLE TECHNOLOGIES, INC.105912016-09-22
00613703106308VanishPoint®RETRACTABLE TECHNOLOGIES, INC.106312016-09-22
00613703110107VanishPoint®RETRACTABLE TECHNOLOGIES, INC.110112016-09-22
00613703110206VanishPoint®RETRACTABLE TECHNOLOGIES, INC.110212016-09-22
00613703110305VanishPoint®RETRACTABLE TECHNOLOGIES, INC.110312016-09-22
00613703110404VanishPoint®RETRACTABLE TECHNOLOGIES, INC.110412016-09-22
00613703110503VanishPoint®RETRACTABLE TECHNOLOGIES, INC.110512016-09-22
00613703110602VanishPoint®RETRACTABLE TECHNOLOGIES, INC.110612016-09-22
00613703110701VanishPoint®RETRACTABLE TECHNOLOGIES, INC.110712016-09-22
00613703110800VanishPoint®RETRACTABLE TECHNOLOGIES, INC.110812016-09-22
00613703110909VanishPoint®RETRACTABLE TECHNOLOGIES, INC.110912016-09-22
00613703130105VanishPoint®RETRACTABLE TECHNOLOGIES, INC.130112016-09-22
00613703130204VanishPoint®RETRACTABLE TECHNOLOGIES, INC.130212016-09-22
00613703152206VanishPoint®RETRACTABLE TECHNOLOGIES, INC.152212016-09-22
00613703152701VanishPoint®RETRACTABLE TECHNOLOGIES, INC.152712016-09-22
00613703152909VanishPoint®RETRACTABLE TECHNOLOGIES, INC.152912016-09-22
00613703153708VanishPoint®RETRACTABLE TECHNOLOGIES, INC.153712018-04-27
00613703153906VanishPoint®RETRACTABLE TECHNOLOGIES, INC.153912018-04-27
00616784691527Safety Syringe w/NeedleDynarex Corporation69152016-09-24
00616784691626Safety Syringe w/NeedleDynarex Corporation69162016-09-24
00616784691725Safety Syringe w/NeedleDynarex Corporation69172016-09-24
00616784691824Safety Syringe w/NeedleDynarex Corporation69182016-09-24
00616784691923Safety Syringe w/NeedleDynarex Corporation69192016-09-24
00616784692029Safety Syringe w/NeedleDynarex Corporation69202016-09-24
00616784692128Safety Syringe w/NeedleDynarex Corporation69212016-09-24
00616784692227Safety Syringe w/NeedleDynarex Corporation69222016-09-24
00616784692326Safety Syringe w/NeedleDynarex Corporation69232016-09-24
00616784692425Safety Syringe w/NeedleDynarex Corporation69242016-09-24
00616784692524Safety Syringe w/NeedleDynarex Corporation69252016-09-24
00616784692623Safety Syringe w/NeedleDynarex Corporation69262016-09-24