FDA.reportPublic FDA data

Advanced Shield Max Silver Barrier, .5oz spray

Primary DI
00858071004089
Brand
Advanced Shield Max Silver Barrier, .5oz spray
Company
Kericure Inc.
Model
6051205
Catalog number
6510-01-727-1987
Device description
Topical burn and wound dressing, antimicrobial barrier with silver, 0.5oz spray
Published
2025-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858071004942PrimaryGS10
00858071004089Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858071004942008580710049428580710049420858071004942
00858071004089008580710040898580710040890858071004089

GMDN Terms#

Term, Definition table
TermDefinition
Skin semi-occlusive dressing, antimicrobialA substance (e.g., gel, cream, ointment) intended to be topically applied to injured/diseased skin to expedite skin healing and re-epithelialization primarily through semi-occlusive properties which reduce moisture transmission from the wound to the environment by means of a physical barrier; it also includes an antimicrobial agent(s). It is intended for home/healthcare facility use to treat open skin wounds (e.g., abrasions, lacerations, burns, surgical wounds, ulcers) and/or conditions (e.g., eczema, psoriasis, scars). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966638681
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858071004843Field Shield Rx Wound Dressing,1oz spray5031610 or 50319106510-01-727-19662025-08-26
00858071004119Field Shield Rx Wound Dressing,0.5oz spray5031605 or 50319056510-01-727-19872025-08-26
00858071004478Natural Shield Wound Dressing, 1oz brush on60208102025-10-06
00858071004553Natural Shield Wound Dressing, 1oz spray60108102025-10-06
00858071004034Natural Seal Wound Dressing 1oz20007102025-10-03
00858071004287Field Shield OTC Wound Dressing, .5oz50318052025-09-12
00858071004195Field Shield OTC Wound Dressing, 1oz50318102025-09-12
00858071004317Advanced Shield Chronic Wound Care, 2oz60112202025-08-08
00858071004348Advanced Shield Hydrogel Silver Wound Barrier GEL, 2oz Tube60412202025-08-26
00858071004171Advanced Shield Max Silver Barrier, 1oz spray60512102025-08-26
00858071004256Advanced Seal Wound Barrier, 1oz spray20003102025-08-21
00858071004881Field Shield Military Wound Dressing5031610C1550316102025-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
01714196112452DermaRite Medical Wound Gel- Amorphous HydrogelSion Brands LLCNAE2026-06-01
00850060751738SkinPenBellus Medical, LLCNAE2026-05-20
00860015727336KegelStar Port IncNAE2026-04-27
10840330704936ProCureTwin Med, LLCNAE2026-04-22
10840330704943ProCureTwin Med, LLCNAE2026-04-22
10840330705803ProCureTwin Med, LLCNAE2026-04-22
10840330705810ProCureTwin Med, LLCNAE2026-04-22
10840330706350ProCureTwin Med, LLCNAE2026-04-22
00324357010155Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357100252Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357104045Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00743537000456First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000470MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
10197344017508MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-10-23
00858071004478Natural Shield Wound Dressing, 1oz brush onKericure Inc.NAE2025-10-06
00858071004553Natural Shield Wound Dressing, 1oz sprayKericure Inc.NAE2025-10-06
20192253040156KendallCardinal Health 200, LLCNAE2025-09-26
00197998326882Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
00197998326967Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
15056860000034Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000041Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000058Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
10197344110162MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-08-04
06974600043672KONLIDASuzhou Konlida Medical Supplies Co., Ltd.NAE2025-07-28
M689HHWSK02050Wound Seal KitSafeguard US Operating, LLCNAE2025-06-24
06971292003694AUVONShenzhen Yuwen E-Commerce Co., Ltd.NAE2025-06-19
06971292003700AUVONShenzhen Yuwen E-Commerce Co., Ltd.NAE2025-06-19
00810040134692SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00810040134708SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00361554005614GentellGentell, LLCNAE2025-02-14