SecureSafe Syringes With Safety Needle

GUDID 00616784892429

DYNAREX CORPORATION

Insulin syringe/needle, safety
Primary Device ID00616784892429
NIH Device Record Key043c0052-2c64-41e8-b17d-7e02df6ab85d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSecureSafe Syringes With Safety Needle
Version Model Number8924
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784892412 [Unit of Use]
GS100616784892429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-04
Device Publish Date2017-10-11

On-Brand Devices [SecureSafe Syringes With Safety Needle]

006167848924298924
006167848922218922
006167848919278919
006167848918288918

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