FDA.reportPublic FDA data

Mighty Patch

Primary DI
00850007468682
Brand
Mighty Patch
Company
Hero Cosmetics, LLC
Model
HK007
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
00850007468682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007468682008500074686828500074686820850007468682

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
00850007468354Mighty PatchHK0022022-10-13
00850007468361Mighty PatchHK0032022-10-13
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

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Primary DI, Brand, Company table
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10840330701614ProCureTwin Med, LLCNAD2026-04-28
10840330701621ProCureTwin Med, LLCNAD2026-04-28
10840330701638ProCureTwin Med, LLCNAD2026-04-28
10840330701645ProCureTwin Med, LLCNAD2026-04-28
10840330701652ProCureTwin Med, LLCNAD2026-04-28
10840330701669ProCureTwin Med, LLCNAD2026-04-28
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10197344169559MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-14
10197344162512MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
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