FDA.reportPublic FDA data

Field Shield Military Wound Dressing

Primary DI
00858071004881
Brand
Field Shield Military Wound Dressing
Company
Kericure Inc.
Model
5031610C15
Catalog number
5031610
Device description
Topical burn and wound dressing, hydrogel barrier antimicrobial with silver and lidocaine, Rx indications, 1oz spray, pack of 15
Published
2025-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
00858071004881PrimaryGS10
00858071004843Unit of UseGS10

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
15
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4Sion Brands LLCFRO2026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4Sion Brands LLCFRO2026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz TubeSion Brands LLCFRO2026-06-01
00850087488259CeeportCEEPORT INC.FRO2026-05-29
00850087488266CeeportCEEPORT INC.FRO2026-05-29
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
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10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
00850087488006CeeportCEEPORT INC.FRO2026-05-22
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781550GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781574GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169443MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05