BURNSHIELD 900820

GUDID 16007645005804

BURNSHIELD ESSENTIAL BURN KIT LARGE

BURNSHIELD (PTY) LTD

Burn gel
Primary Device ID16007645005804
NIH Device Record Key143e6e4c-cc3a-4049-9573-49b11dbf25dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBURNSHIELD
Version Model Number900820
Catalog Number900820
Company DUNS635842958
Company NameBURNSHIELD (PTY) LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+27114405171
Emailsales@burnshield.com
Phone+27114405171
Emailsales@burnshield.com
Phone+27114405171
Emailsales@burnshield.com
Phone+27114405171
Emailsales@burnshield.com
Phone+27114405171
Emailsales@burnshield.com
Phone+27114405171
Emailsales@burnshield.com
Phone+27114405171
Emailsales@burnshield.com
Phone+27114405171
Emailsales@burnshield.com
Phone+27114405171
Emailsales@burnshield.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106007645005807 [Primary]
GS116007645005804 [Package]
Contains: 06007645005807
Package: BOX [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-08-24
Device Publish Date2019-08-02

On-Brand Devices [BURNSHIELD]

06007645007917BURNSHIELD BLANK WOOL 1.6x1.8m(64X71")
16007645007679BURNSHIELD CONTOUR KIT DOUBLE
16007645007662BURNSHIELD CONTOUR KIT SINGLE
26007645006358MUNDIAL HOME/TRAVEL KIT
16007645006054BURNSHIELD BURN BLOTTS 0.9G
16007645006047BURNSHIELD HYDROGEL 50ML SPRAY
16007645003954BURNSHIELD 60X40CM FACEMASK
06007645003537BURNSHIELD CONTOUR 1X2M
16007645003527BURNSHIELD CONTOUR 1X1M
06007645002073BURNSHIELD TWIN BLANKET 1.2X1.6M
26007645001452BURNSHIELD 20X45CM FACEMASK
26007645001414BURNSHIELD DRESS 20x45cm (8x18")
16007645001400BURNSHIELD 60X40CM DRESSINGS
06007645001397BURNSHIELD 20X20CM DRESSINGS
96007645001383BURNSHIELD 10X10CM DRESSINGS IN BULK
16007645000212BURNSHIELD BURN BLOTTS 3.5ML
36007645000193BURNSHIELD HYD SPRAY BOTTLE 125ML(4.5oz)
06007645000222BURNSHIELD BLANK WOOL 1.2x1.6m(48x64")
16007645007655BURNSHIELD DRESS CONTOUR 1X2M(40X80 )BAG
16007645007648BURNSHIELD DRESS CONTOUR 1X1M(40X40 )BAG
36007645005303BURNSHIELD HYDROGEL TUBE 25ML (0.85 OZ)
26007645004590BURNSHIELD HYDROGEL TUBE 10ML (0.35 OZ)
36007645001541BURNSHIELD MINI BURN KIT
06007645000161BURNSHIELD BLANK WOOL 2.45mx1.6m(98"X64")
16007645001431BURNSHIELD DRESSING 25MMX0.50M (1X20") DIGIT
16007645004302BURNSHIELD HYDROGEL SPRAY BOTTLE 75ML (2.70oz)
16007645006344MUNDIAL DRESSING 10CMX10CM (4X4") (2'S)
16007645006337MUNDIAL BURN KIT
16007645005804BURNSHIELD ESSENTIAL BURN KIT LARGE
16007645001424BURNSHIELD DRESSING 50MMX1M (2X40") LIMB
16007645000120BURNSHIELD HYDROGEL BOTTLE 50ML (1.8OZ)
16007645007921BURNSHIELD EMERGENCY KIT IN NYLON BAG
16007645002001BURNSHIELD CATER KIT
16007645005781BURNSHIELD ESSENTIAL BURN KIT SMALL

Trademark Results [BURNSHIELD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BURNSHIELD
BURNSHIELD
87262226 5399210 Live/Registered
Levtrade International (Pty) Ltd
2016-12-08
BURNSHIELD
BURNSHIELD
86616015 not registered Dead/Abandoned
Natureplex, LLC
2015-04-30
BURNSHIELD
BURNSHIELD
74213418 not registered Dead/Abandoned
Levtrade International (PTY) Ltd.
1991-10-16

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