Biotronix Healthcare Hypodermic Needles GE36412

GUDID 20858835007954

DISPOSABLE HYPODERMIC NEEDLE 22G X 1 1/2"

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Hypodermic needle, single-use
Primary Device ID20858835007954
NIH Device Record Key14a5153b-ba96-4ca9-bdc9-dee5ff2b32ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiotronix Healthcare Hypodermic Needles
Version Model NumberGE36412
Catalog NumberGE36412
Company DUNS065762392
Company NameBIOTRONIX HEALTHCARE INDUSTRIES, INC.
Device Count1
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com
Phone786-473-9436
Emailmborges@biotronixhealthcare.com

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Device Identifiers

Device Issuing AgencyDevice ID
GS100858835007950 [Primary]
GS110858835007957 [Package]
Contains: 00858835007950
Package: Inner Box [100 Units]
In Commercial Distribution
GS120858835007954 [Package]
Contains: 10858835007957
Package: Case [20 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 Number3
Public Version Date2019-12-24
Device Publish Date2019-10-06

On-Brand Devices [Biotronix Healthcare Hypodermic Needles]

20858835007978HYPODERMIC NEEDLE 25G X 5/8"
20858835007961DISPOSABLE HYPODERMIC NEEDLE 22G X 1"
20858835007954DISPOSABLE HYPODERMIC NEEDLE 22G X 1 1/2"

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