FDA.reportPublic FDA data

BMI

Primary DI
G088ESOXX0
Brand
BMI
Company
Blake Manufacturing, Inc.
Model
ESO-XX
Catalog number
ESO-XX
Device description
Elbow Static Orthosis, size Extra-Large/Extra-Large
Published
2021-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G088ESOXX0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Elbow orthosisAn externally applied orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103449711
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G088KCALL0BMIKCA-LLKCA-LL2022-09-21
G088KCALR0BMIKCA-LRKCA-LR2022-09-21
G088KCAML0BMIKCA-MLKCA-ML2022-09-21
G088KCAMR0BMIKCA-MRKCA-MR2022-09-21
G088KCAPL0BMIKCA-PLKCA-PL2022-09-21
G088KCAPR0BMIKCA-PRKCA-PR2022-09-21
G088KCASL0BMIKCA-SLKCA-SL2022-09-21
G088KCASR0BMIKCA-SRKCA-SR2022-09-21
G088KCAXL0BMIKCA-XLKCA-XL2022-09-21
G088KCAXR0BMIKCA-XRKCA-XR2022-09-21
G088KCAXXL0BMIKCA-XXLKCA-XXL2022-09-21
G088KCAXXR0BMIKCA-XXRKCA-XXR2022-09-21
G088DSKCALL0PanaceaDS-KCA-LLDS-KCA-LL2022-09-20
G088DSKCALR0PanaceaDS-KCA-LRDS-KCA-LR2022-09-20
G088DSKCAML0PanaceaDS-KCA-MLDS-KCA-ML2022-09-20
G088DSKCAMR0PanaceaDS-KCA-MRDS-KCA-MR2022-09-20
G088DSKCAPL0PanaceaDS-KCA-PLDS-KCA-PL2022-09-20
G088DSKCAPR0PanaceaDS-KCA-PRDS-KCA-PR2022-09-20
G088DSKCASL0PanaceaDS-KCA-SLDS-KCA-SL2022-09-20
G088DSKCASR0PanaceaDS-KCA-SRDS-KCA-SR2022-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257213322MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213339MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213346MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213353MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213360MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213377MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213384MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213391MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00645517899312TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899329TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899336TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899343TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899398TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899404TrulifeTRULIFE LIMITEDIQI2026-04-22
00810075281620BoneFoamBONE FOAM, INC.IQI2025-08-15
10841156111298ACCUMEDTELEFLEX INCORPORATEDIQI2025-03-11
10841156111304ACCUMEDTELEFLEX INCORPORATEDIQI2025-03-11
00810079190102Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190119Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190126Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190133Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190140Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190157Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190164Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190171Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191703The Equinus BraceThrive Orthopedics LLCIQI2024-12-10
00810079191710Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191727Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191734Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191741Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10