Burn Stop BSG350R.02.000

GUDID 00743537000845

Burn Stop Unit Dose 1728/cs for WJE; BD Gel

WATER-JEL TECHNOLOGIES, L.L.C.

Burn gel
Primary Device ID00743537000845
NIH Device Record Key4eb5bce5-6ec6-4e24-815d-40746ecdc6ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameBurn Stop
Version Model NumberBSG350R.02.000
Catalog NumberBSG350R.02.000
Company DUNS155522589
Company NameWATER-JEL TECHNOLOGIES, L.L.C.
Device Count1728
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone855-428-6074
Emailsales@safeguardmedical.com
Phone855-428-6074
Emailsales@safeguardmedical.com
Phone855-428-6074
Emailsales@safeguardmedical.com
Phone855-428-6074
Emailsales@safeguardmedical.com
Phone855-428-6074
Emailsales@safeguardmedical.com
Phone855-428-6074
Emailsales@safeguardmedical.com
Phone855-428-6074
Emailsales@safeguardmedical.com
Phone855-428-6074
Emailsales@safeguardmedical.com
Phone855-428-6074
Emailsales@safeguardmedical.com
Phone855-428-6074
Emailsales@safeguardmedical.com
Phone855-428-6074
Emailsales@safeguardmedical.com
Phone855-428-6074
Emailsales@safeguardmedical.com
Phone855-428-6074
Emailsales@safeguardmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100743537000845 [Unit of Use]
GS100743537000852 [Primary]

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 Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-11
Device Publish Date2024-11-01

On-Brand Devices [Burn Stop]

00743537001064WJ Burn Stop Unit Dose 1728/cs; Cool Jel
00743537000845Burn Stop Unit Dose 1728/cs for WJE; BD Gel

Trademark Results [Burn Stop]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BURN STOP
BURN STOP
76539648 3187741 Live/Registered
WATER-JEL TECHNOLOGIES, LLC
2003-08-25
BURN STOP
BURN STOP
74028259 1625597 Dead/Cancelled
Dixie USA, Inc.
1990-02-12

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