Secure Safe Allergy Tray

GUDID 00616784893631

DYNAREX CORPORATION

Insulin syringe/needle, safety
Primary Device ID00616784893631
NIH Device Record Key0ef1d897-56f5-421c-9c24-f47fedbdd9a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSecure Safe Allergy Tray
Version Model Number8936
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count40
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784893617 [Unit of Use]
GS100616784893631 [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 Number3
Public Version Date2018-07-06
Device Publish Date2017-10-11

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