FDA.reportPublic FDA data

DARCO® Body Armor® Toe Guard

Primary DI
00609271009110
Brand
DARCO® Body Armor® Toe Guard
Company
DARCO INTERNATIONAL, INC.
Model
BATGQ2
Catalog number
BATGQ2
Device description
Large Black Square-toe
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FMPProtector, skin pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609271009117PackageGS112In Commercial Distribution
20609271009114PackageGS136In Commercial Distribution
00609271009110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927100911710609271009117
2060927100911420609271009114
00609271009110006092710091106092710091100609271009110

GMDN Terms#

Term, Definition table
TermDefinition
Foot friction/impact protectorA device designed to be worn over/on the foot, often while wearing shoes, to provide a cushion to protect the whole foot or parts of the foot (e.g., toes, metatarsal heads, heel) from friction against surfaces or knocks against objects, to relieve pain during walking, and/or to prevent formation of hard areas and callouses. It is typically made of soft-padded or gel materials in a variety of forms (e.g., strip, pad, elastic band, digital tube), and some types may be inflatable or held in place with bands or straps around the foot. It is not specifically designed to protect a bunion. This is a reusable device.

Regulatory Flags#

DUNS number
184231298
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00609271999336Aircore™ Offloading InsoleACI02026-07-20
00609271999343Aircore™ Offloading InsoleACI12026-07-20
00609271999374Aircore™ Offloading InsoleACI42026-07-20
00609271999381Aircore™ Offloading InsoleACI52026-07-20
00609271999473Aircore™ Offloading InsoleACI22026-07-20
00609271999480Aircore™ Offloading InsoleACI32026-07-20
00609271989603Aircore™ Offloading InsoleACIP0602026-01-07
00609271989610Aircore™ Offloading InsoleACIP0702026-01-07
00609271989627Aircore™ Offloading InsoleACIP0752026-01-07
00609271989634Aircore™ Offloading InsoleACIP0802026-01-07
00609271989658Aircore™ Offloading InsoleACIP0902026-01-07
00609271989665Aircore™ Offloading InsoleACIP0952026-01-07
00609271989672Aircore™ Offloading InsoleACIP1002026-01-07
00609271989689Aircore™ Offloading InsoleACIP1052026-01-07
00609271989696Aircore™ Offloading InsoleACIP1102026-01-07
00609271989702Aircore™ Offloading InsoleACIP1152026-01-07
00609271989719Aircore™ Offloading InsoleACIP1202026-01-07
00609271989726Aircore™ Offloading InsoleACIP1252026-01-07
00609271989733Aircore™ Offloading InsoleACIP1302026-01-07
00609271989740Aircore™ Offloading InsoleACIP1352026-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00089904011510Action®ACTION PRODUCTS, INC.FMP2026-10-14
00089904011527Action®ACTION PRODUCTS, INC.FMP2026-10-14
00850018561037Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561044Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561051Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561068SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561075SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561082SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00089904011503Action®ACTION PRODUCTS, INC.FMP2026-09-30
07333350181475Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350455873Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350647292Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350775360Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350462161Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
00860015694713Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694720Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694737Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694744Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694751Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694768Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00089904011459Action®ACTION PRODUCTS, INC.FMP2026-07-23
00089904011435Action®ACTION PRODUCTS, INC.FMP2026-07-21
00089904011442Action®ACTION PRODUCTS, INC.FMP2026-07-21
00609271999336Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999343Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999374Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999381Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20