Bio-Gaurd Safety Needles BIO-1011S

GUDID 20858835007794

Disposable Bio-Gaurd Safety Needles 18G x 1"

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Hypodermic needle, single-use
Primary Device ID20858835007794
NIH Device Record Key36b5cd2c-5e96-4356-9e74-106d9b46106d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio-Gaurd Safety Needles
Version Model NumberBIO-1011S
Catalog NumberBIO-1011S
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
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
GS100858835007790 [Primary]
GS110858835007797 [Package]
Contains: 00858835007790
Package: Inner Box [100 Units]
In Commercial Distribution
GS120858835007794 [Package]
Contains: 10858835007797
Package: Case [8 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 Date2019-10-10

Devices Manufactured by BIOTRONIX HEALTHCARE INDUSTRIES, INC.

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