FDA.reportPublic FDA data

Health Design Polycast Cast Boot

Primary DI
00609271000452
Brand
Health Design Polycast Cast Boot
Company
DARCO INTERNATIONAL, INC.
Model
HD-CB-PC6
Catalog number
HD-CB-PC6
Device description
Extra-large Black
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
IPGSHOE, CAST

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPGShoe, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609271000459PackageGS112In Commercial Distribution
20609271000456PackageGS136In Commercial Distribution
00609271000452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927100045910609271000459
2060927100045620609271000456
00609271000452006092710004526092710004520609271000452

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
00749756888349DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888356DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888370DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888387DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888394DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888400DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00810178880577Vive VIVE HEALTH LLCIPG2025-10-14
00810178880584Vive VIVE HEALTH LLCIPG2025-10-14
00810178880591Vive VIVE HEALTH LLCIPG2025-10-14
00810178880607Vive VIVE HEALTH LLCIPG2025-10-14
00810178880614Vive VIVE HEALTH LLCIPG2025-10-14
00810178880621Vive VIVE HEALTH LLCIPG2025-10-14
00810178880638Vive VIVE HEALTH LLCIPG2025-10-14
G0648317270026770GAITKEEPER® Cast Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270026840GAITKEEPER® Cast Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270026910GAITKEEPER® Cast Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270027520Position Health® Classic Post-Op Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270027690Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
G0648317270027760Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
G0648317270027830Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
G0648317270027900Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
00810113576398CoreTechVIVE HEALTH LLCIPG2024-06-10
00810113576404CoreTechVIVE HEALTH LLCIPG2024-06-10
00810113576411CoreTechVIVE HEALTH LLCIPG2024-06-10
00810113576428CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576395CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576401CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576418CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576425CoreTechVIVE HEALTH LLCIPG2024-06-10
00810113575971VIVEVIVE HEALTH LLCIPG2024-06-05