FDA.reportPublic FDA data

CoreTech

Primary DI
00810113576398
Brand
CoreTech
Company
VIVE HEALTH LLC
Model
SUP3059BLKS
Device description
Hard Night Splint (Small)
Published
2024-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
10810113576395PackageGS116In Commercial Distribution
00810113576398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357639510810113576395
00810113576398008101135763988101135763980810113576398

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810041982483ViveLVA2057BLU2026-05-14
00818323022797ViveLVA1003PAK2 2026-05-11
00818323025279ViveLVA10032026-05-11
00810113576817ViveLVA3049BLKML6M72024-07-17
00810113576824ViveLVA3049BLKCM92024-07-17
00810113576831ViveLVA3049BLKBM62024-07-17
00810113579627ViveLVA3078WHTS2025-04-04
00810113579634ViveLVA3078WHTM2025-04-04
00810113579641ViveLVA3078WHTL2025-04-04
00810113579658ViveLVA3078WHTL2025-04-04
00810178883516ViveLVA3099BLK2025-07-17
00818323025002VIVELVA1099BLK2019-03-24
00818323025019VIVELVA1099GRY2019-03-24
00818323025026VIVELVA1099PUR2019-03-24
00810178883639ViveLVA3102BLK2025-08-07
00810178883301ViveLVA3098BLK2025-07-17
00810178883523ViveLVA3100BLK2025-07-17
00810178883530ViveLVA3100PUR2025-07-17
00810178881857ViveLVA3086BLUS2025-07-15
00810178881864ViveLVA3086BLUM2025-07-15

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
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
10810113575978VIVEVIVE HEALTH LLCIPG2024-06-05