Pen Needles

GUDID 00616784702438

DYNAREX CORPORATION

Hypodermic needle, single-use
Primary Device ID00616784702438
NIH Device Record Key55762ae0-352a-4840-a733-6a3e9bc24389
Commercial Distribution StatusIn Commercial Distribution
Brand NamePen Needles
Version Model Number7024
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784702414 [Unit of Use]
GS100616784702421 [Primary]
GS100616784702438 [Package]
Contains: 00616784702421
Package: [10 Units]
In Commercial Distribution

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 Date2016-09-24

On-Brand Devices [Pen Needles]

006167847028347028
006167847027357027
006167847026367026
006167847025377025
006167847024387024

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