FDA.reportPublic FDA data

BURNSHIELD

Primary DI
16007645000120
Brand
BURNSHIELD
Company
BURNSHIELD (PTY) LTD
Model
550000
Catalog number
550000
Device description
BURNSHIELD HYDROGEL BOTTLE 50ML (1.8OZ)
Published
2021-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943728000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943728000BURNFREE BURNSOOTHE HYDROGELLevtrade Intl. (Pty) , Ltd.1994-09-27MGQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16007645000120PackageGS16In Commercial Distribution
26007645000127PackageGS112In Commercial Distribution
06007645000123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1600764500012016007645000120
2600764500012726007645000127
06007645000123060076450001236007645000123

GMDN Terms#

Term, Definition table
TermDefinition
Burn gelA substance intended to be applied directly to a minor burn or sunburn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is typically available in sachets, bottles, or spray containers as a gel or spray and is used by emergency medical services (EMS) and critical care units, but may also be used in the home. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume50Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+27114405171sales@burnshield.com

Regulatory Flags#

DUNS number
635842958
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06007645000215Burnshield5500045500042018-11-01
06007645005784BURNSHIELD9008189008182023-11-04
16007645005781BURNSHIELD9008189008182023-11-04
06007645001380Burnshield9011119011112018-12-17
00830868000030ARAMARK9011389011382022-06-01
10830868000037ARAMARK9011389011382022-06-01
06007645002004BURNSHIELD9030019030012021-12-10
06007645007924BURNSHIELD9008179008172021-12-11
16007645002001BURNSHIELD9030019030012021-12-10
16007645007921BURNSHIELD9008179008172021-12-11
06007645000123BURNSHIELD5500005500002021-08-20
06007645000192Burnshield5500035500032018-12-17
06007645001403Burnshield9010079010072018-12-17
06007645001410Burnshield9010019010012018-11-01
06007645001427BURNSHIELD9011319011312020-11-11
06007645001434BURNSHIELD9011309011302020-08-07
06007645001458Burnshield9010009010002018-11-01
06007645001540BURNSHIELD5500135500132020-07-25
06007645003520Burnshield8810068810062018-12-17
06007645003957Burnshield9011359011352018-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00368040753141Promiseb Topical CreamPrimus Pharmaceuticals, Inc.MGQ2026-05-01
00850058790114RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790121RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790138G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790145G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790152G4Derm PlusGel4med, Inc.MGQ2025-10-17
00383160000104Dash TopicAIM MEDICAL INC.MGQ2025-05-12
00850058790060SuprelloGel4med, Inc.MGQ2025-03-25
00850058790084SuprelloGel4med, Inc.MGQ2025-03-25
00850058790091SuprelloGel4med, Inc.MGQ2025-03-25
00860013569907MuGardSoleva Pharma LLCMGQ2025-02-28
00743537000791BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000814BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000838BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000852Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000913Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000937Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000951Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000975Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000999Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001019Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001033Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001057Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001071Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001095Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000784BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000807BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000821BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000845Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000906Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01