FDA.reportPublic FDA data

Panacea

Primary DI
G088DSECOXR0
Brand
Panacea
Company
Blake Manufacturing, Inc.
Model
DS-ECO-XR
Catalog number
DS-ECO-XR
Device description
Panacea Elbow Corrective orthosis, size X-Large/Right
Published
2022-09-02
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
IQIOrthosis, Limb Brace

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G088DSECOXR0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Elbow orthosisA prefabricated (non-customized) externally applied and wearable 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
00810079192656Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192663Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192670Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192687Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192694Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192700Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192717Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192724Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192731Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192748Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192755Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192762Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192779Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192786Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192793Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192809Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192816Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192823Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192946Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192953Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192960Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192977Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192984Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192991Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193004Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193011Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193028Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00636257213322MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213339MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213346MEDIMEDI MANUFACTURING, INC.IQI2026-04-24