FDA.reportPublic FDA data

POSEY

Primary DI
10190676006516
Brand
POSEY
Company
POSEY PRODUCTS, LLC
Model
6218
Catalog number
6218
Device description
PROHEELX HEEL PROTECTOR
Published
2022-10-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
20190676006513PackageGS18Not in Commercial Distribution
10190676006516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019067600651320190676006513
1019067600651610190676006516

Regulatory Flags#

DUNS number
008503294
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190676007653Posey8309WL8309WL2024-10-23
10190676008336Posey8283WL2026-09-24
30618125134718Grip-Lok3400LFC-10PK2024-12-02
10190676005632POSEYV2531V25312022-10-05
10190676005656POSEYV2550V25502022-10-05
10190676005663POSEYV2551V25512022-10-05
10190676005670POSEYV2811V28112022-10-05
10190676005687POSEYV2816V28162022-10-05
10190676005694POSEYV2819V28192022-10-05
10190676006301POSEYV8309ELV8309EL2022-10-06
10190676006318POSEYV8309V83092022-10-06
10190676001924POSEY EYE PROTECTORS46442022-08-04
10190676001948POSEY464646462022-10-06
10190676003867POSEY833383332022-10-06
10190676003874POSEY831683162022-10-05
10190676004383POSEY833283322022-10-06
10190676005649POSEYV2532V25322022-10-05
10190676006295POSEYV8283V82832022-10-06
10618125190666POSEY8334WL8334WL2022-11-02
10190676002013POSEY820882082022-10-04

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