SecureSafe Safety Hyperdermic Needles

GUDID 00616784896021

DYNAREX CORPORATION

Hypodermic needle, single-use
Primary Device ID00616784896021
NIH Device Record Keyf09f872e-ecf0-42e3-be1d-053f53b3d339
Commercial Distribution StatusIn Commercial Distribution
Brand NameSecureSafe Safety Hyperdermic Needles
Version Model Number8960
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
GS100616784896014 [Unit of Use]
GS100616784896021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-23
Device Publish Date2017-10-16

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