Biotronix Healthcare Hypodermic Needles GE36411

GUDID 20858835007961

DISPOSABLE HYPODERMIC NEEDLE 22G X 1"

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Hypodermic needle, single-use
Primary Device ID20858835007961
NIH Device Record Keyaed1e6c8-9778-4e1f-8f85-e373e57c4254
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiotronix Healthcare Hypodermic Needles
Version Model NumberGE36411
Catalog NumberGE36411
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
GS100858835007967 [Primary]
GS110858835007964 [Package]
Contains: 00858835007967
Package: Inner Box [100 Units]
In Commercial Distribution
GS120858835007961 [Package]
Contains: 10858835007964
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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