SecureSafe Safety Insulin Syringe

GUDID 00616784890128

DYNAREX CORPORATION

Insulin syringe/needle, safety
Primary Device ID00616784890128
NIH Device Record Key09cbee6d-b359-4903-a8b6-de043449b210
Commercial Distribution StatusIn Commercial Distribution
Brand NameSecureSafe Safety Insulin Syringe
Version Model Number8901
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 Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784890111 [Unit of Use]
GS100616784890128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston
MEGSyringe, Antistick

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-16

On-Brand Devices [SecureSafe Safety Insulin Syringe]

006167848905248905
006167848904258904
006167848903268903
006167848902278902
006167848901288901

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