FDA.reportPublic FDA data

Field Shield Rx Wound Dressing,0.5oz spray

Primary DI
00858071004119
Brand
Field Shield Rx Wound Dressing,0.5oz spray
Company
Kericure Inc.
Model
5031605 or 5031905
Catalog number
6510-01-727-1987
Device description
Topical burn and wound dressing, hydrogel barrier antimicrobial with silver and lidocaine, Rx indications, 0.5oz 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
00858071004935PrimaryGS10
00858071004119Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858071004935008580710049358580710049350858071004935
00858071004119008580710041198580710041190858071004119

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
00858071004843Field Shield Rx Wound Dressing,1oz spray5031610 or 50319106510-01-727-19662025-08-26
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

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Primary DI, Brand, Company table
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00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
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00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998002861Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173523Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173554Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432415Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
00050428034873CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28