FDA.reportPublic FDA data

Panacea

Primary DI
G088DSHKOS0
Brand
Panacea
Company
Blake Manufacturing, Inc.
Model
DS-HKO-S
Catalog number
DS-HKO-S
Device description
Panacea Hip-Knee orthosis, size Small
Published
2022-09-06
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
IOZSplint, Abduction, Congenital Hip Dislocation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOZSplint, Abduction, Congenital Hip DislocationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G088DSHKOS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hip orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or improve function of the hip; it is not dedicated to infants. It is typically adjustable and comprised of components that include a hip/pelvic girdle, thigh cuff, and articulated hip portion. 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
H93350840100Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840110Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840120Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840210Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840245Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840250Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93300267100100Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
H93300267100200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
H93300267100300Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
H93300267500000Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
00645517327983TrulifeTRULIFE LIMITEDIOZ2022-12-31
00645517327990TrulifeTRULIFE LIMITEDIOZ2022-12-31
00645517328003TrulifeTRULIFE LIMITEDIOZ2022-12-31
G088DSHKOR0PanaceaBlake Manufacturing, Inc.IOZ2022-09-06
G088HKOR0BMIBlake Manufacturing, Inc.IOZ2022-08-15
G088HKOS0BMIBlake Manufacturing, Inc.IOZ2022-08-15
00749756018029DeRoyalDEROYAL INDUSTRIES, INC.IOZ2021-07-29
00749756018036DeRoyalDEROYAL INDUSTRIES, INC.IOZ2021-07-29
00749756018043DeRoyalDEROYAL INDUSTRIES, INC.IOZ2021-07-29
00889024369207N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00889024369214N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00889024369221N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00889024369283N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00696588003580Slimline™ Abduction Pillow Innovative Medical Products, IncIOZ2020-06-02
00696588003597Slimline™ Abduction Pillow Innovative Medical Products, IncIOZ2020-06-02
00696588003795Pediatric Abduction PillowInnovative Medical Products, IncIOZ2020-06-02
00696588003818Universal Abduction PillowInnovative Medical Products, IncIOZ2020-06-02
00696588005447Slimline™ Abduction Pillow Innovative Medical Products, IncIOZ2020-06-02
00696588005485Pediatric Abduction PillowInnovative Medical Products, IncIOZ2020-06-02
00696588006116Universal Abduction PillowInnovative Medical Products, IncIOZ2020-06-02