FDA.reportPublic FDA data

Field Shield Rx Wound Dressing,1oz spray

Primary DI
00858071004843
Brand
Field Shield Rx Wound Dressing,1oz spray
Company
Kericure Inc.
Model
5031610 or 5031910
Catalog number
6510-01-727-1966
Device description
Topical burn and wound dressing, hydrogel barrier antimicrobial with silver and lidocaine, Rx indications, 1oz spray
Published
2025-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212521000Field Shield Wound DressingKericure, Inc.2024-07-18FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858071004881PackageGS115In Commercial Distribution
00858071004843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858071004881008580710048818580710048810858071004881
00858071004843008580710048438580710048430858071004843

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00858071004089Advanced Shield Max Silver Barrier, .5oz spray60512056510-01-727-19872025-08-26
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
00612553000163VERISHARTMANN USA, INC.FRO2026-10-01
00612553000170VERISHARTMANN USA, INC.FRO2026-10-01
00612553000187VERISHARTMANN USA, INC.FRO2026-10-01
00612553000194VERISHARTMANN USA, INC.FRO2026-10-01
00194346726707equateWAL-MART STORES, INC.FRO2026-09-30
00194346726714equateWAL-MART STORES, INC.FRO2026-09-30
10885380214714CurityCardinal Health 200, LLCFRO2026-09-30
10885380214738CurityCardinal Health 200, LLCFRO2026-09-30
00810226440944ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440951ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440968ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442542ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442559ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442566ViveCareVIVE HEALTH LLCFRO2026-09-29
00810178885329Vive CareVIVE HEALTH LLCFRO2026-09-28
10885380214707CurityCardinal Health 200, LLCFRO2026-09-28
10885380214721CurityCardinal Health 200, LLCFRO2026-09-28
10885380214745CurityCardinal Health 200, LLCFRO2026-09-28
10885380214752CurityCardinal Health 200, LLCFRO2026-09-28
10885380214769CurityCardinal Health 200, LLCFRO2026-09-28
10885380214776CurityCardinal Health 200, LLCFRO2026-09-28
10885380214783CurityCardinal Health 200, LLCFRO2026-09-28
10885380214790CurityCardinal Health 200, LLCFRO2026-09-28
10885380214806CurityCardinal Health 200, LLCFRO2026-09-28
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26