FDA.reportPublic FDA data

Mighty Patch

Primary DI
00850007468354
Brand
Mighty Patch
Company
Hero Cosmetics, LLC
Model
HK002
Published
2022-10-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850007468354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007468354008500074683548500074683540850007468354

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
053668306
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007468071Mighty PatchMPB0012022-10-13
00850007468361Mighty PatchHK0032022-10-13
00850007468682Mighty PatchHK0072022-10-13
00850007468903Mighty PatchMP0212022-10-13
00850007468002Mighty PatchMP0092022-04-01
00850007468088Mighty PatchMP0132022-04-01
00850007468095Mighty PatchMP0122022-04-01
00850007468125Mighty PatchMP002EU2022-04-01
00850007468132Mighty PatchMP006EU2022-04-01
00850007468415Mighty PatchMP0142022-04-01
00850007468446Mighty PatchMP0152022-04-01
00850007468606Mighty PatchMP0162022-04-01
00864475000404Mighty PatchMP0012022-04-01
00864475000411Mighty PatchMP0022022-04-01
00864475000428Mighty PatchMP0032022-04-01
00864475000435Mighty PatchMP004EU2022-04-01
00864475000442Mighty PatchMP0042022-04-01
00864475000459Mighty PatchMP0052022-04-01
00864475000466Mighty PatchMP0062022-04-01
00864475000480Mighty PatchMP0082022-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
040640351931573M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
040640351931953M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
040640351932323M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
05060483573083Russell Chest Seal - Twin (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-24
05060483570006Russell Chest Seal (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-20
00850088144642CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144659CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144697CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144215CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144222CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144239CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144246CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144253CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144000CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850088144017CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850087488686CeeportCEEPORT INC.NAD2026-06-30
06970206823946Dr Perfect Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206823977kegel Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827067Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827074Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827081Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827098Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827104Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828149Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828156Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828163Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828170Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
10885632506000HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
10885632506017HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
10885632506024HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05