Biotronix Healthcare OR4004

GUDID 10850005165054

Minor Laceration Tray w/ Instrument

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

General/plastic surgical procedure kit, non-medicated, single-use
Primary Device ID10850005165054
NIH Device Record Key21a1849c-7d42-44f5-8bcb-90592bfa6bea
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiotronix Healthcare
Version Model NumberOR4004
Catalog NumberOR4004
Company DUNS065762392
Company NameBIOTRONIX HEALTHCARE INDUSTRIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005165057 [Primary]
GS110850005165054 [Package]
Contains: 00850005165057
Package: Case [20 Units]
In Commercial Distribution

FDA Product Code

KDDKit, Surgical Instrument, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-24
Device Publish Date2019-10-04

On-Brand Devices [Biotronix Healthcare]

20858835007053Disposable Hypodermic Needles 23G x 1"
20858835007046Disposable Hypodermic Needles 22G x 1 1/2"
20858835007039Disposable Hypodermic Needle 21G x 1 1/2
20858835007022Disposable Hypodermic Needle 20G x 1 1/2"
20858835007015Disposable Hypodermic Needle 18G x 1 1/2"
20858835007008Disposable Hypodermic Needles 18G x 1"
10850005165283Enteral Delivery Gravity Bag Set w/ ENFit™* Connector
10850005165276Enteral Delivery Pump Bag Set w/ ENFit™* Connector
10850005165108Nebulizer with Pediatric Elongated Mask, 7ft. No Crush Tubing and Standard Connector
10850005165092Nebulizer with Adult Mask, 7ft. No Crush Tubing and Standard Connector
10850005165078Nebulizer with Elongated Adult Mask, 7ft. No Crush Tubing and Universal Connector
10850005165054Minor Laceration Tray w/ Instrument
10850005165047Irrigation Tray with Piston Syringe
10850005165030Irrigation Tray with Bulb Syringe

Trademark Results [Biotronix Healthcare]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOTRONIX HEALTHCARE
BIOTRONIX HEALTHCARE
86094840 4616297 Live/Registered
Biotronix Healthcare Industries Inc.
2013-10-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.