FDA.reportPublic FDA data

Rhino

Primary DI
00810060887332
Brand
Rhino
Company
MD ORTHOPAEDICS, INC.
Model
Cruiser Hip Abduction Brace Pink - Extra Large
Catalog number
27095
Device description
Cruiser Hip Abduction Brace Pink - Extra Large
Published
2024-01-09
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
ITSJoint, Hip, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITSJoint, Hip, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060887332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060887332008100608873328100608873320810060887332

GMDN Terms#

Term, Definition table
TermDefinition
Infant hip harnessA prefabricated (non-customized) soft orthopaedic orthosis intended to be worn by an infant to help keep the hips and knees bent and the thighs spread apart, typically to treat developmental dysplasia of the hip (DDH). Also referred to as a Pavlik harness, it is in the form of a vest-like harness with adjustable padded straps whereby the infant’s legs are suspended from the shoulders and chest. This is a reusable device.

Regulatory Flags#

DUNS number
146220269
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
00810060888674Mitchell Ponseti® Bracing SystemAFO-0000-PRCDAFO-0000-PRCD2026-04-30
00810060888681Mitchell Ponseti® Bracing SystemAFO-000-PRCDAFO-000-PRCD2026-04-30
00810060888698Mitchell Ponseti® Bracing SystemAFO-00-PRCDAFO-00-PRCD2026-04-30
00810060888704Mitchell Ponseti® Bracing SystemAFO-0-PRCDAFO-0-PRCD2026-04-30
00810060888711Mitchell Ponseti® Bracing SystemAFO-1-PRCDAFO-1-PRCD2026-04-30
00810060888728Mitchell Ponseti® Bracing SystemAFO-2-PRCDAFO-2-PRCD2026-04-30
00810060888735Mitchell Ponseti® Bracing SystemAFO-3-PRCDAFO-3-PRCD2026-04-30
00810060888742Mitchell Ponseti® Bracing SystemAFO-4-PRCDAFO-4-PRCD2026-04-30
00810060888759Mitchell Ponseti® Bracing SystemAFO-5-PRCDAFO-5-PRCD2026-04-30
00810060888766Mitchell Ponseti® Bracing SystemAFO-6-PRCDAFO-6-PRCD2026-04-30
00810060888773Mitchell Ponseti® Bracing SystemAFO-7-PRCDAFO-7-PRCD2026-04-30
00810060888780Mitchell Ponseti® Bracing SystemAFO-8-PRCDAFO-8-PRCD2026-04-30
00810060888797Mitchell Ponseti® Bracing SystemAFO-9-PRCDAFO-9-PRCD2026-04-30
00810060888803Mitchell Ponseti® Bracing SystemAFO-10-PRCDAFO-10-PRCD2026-04-30
00810060888810Mitchell Ponseti® Bracing SystemAFO-11-PRCDAFO-11-PRCD2026-04-30
00810060888827Mitchell Ponseti® Bracing SystemAFO-12-PRCDAFO-12-PRCD2026-04-30
00810060888834Mitchell Ponseti® Bracing SystemAFO-2-LCD -TSAFO-2-LCD -TS2026-04-30
00810060888841Mitchell Ponseti® Bracing SystemAFO-2-RCD -TSAFO-2-RCD -TS2026-04-30
00810060888858Mitchell Ponseti® Bracing SystemAFO-3-LCD -TSAFO-3-LCD -TS2026-04-30
00810060888865Mitchell Ponseti® Bracing SystemAFO-3-RCD -TSAFO-3-RCD -TS2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178884742CoreTechVIVE HEALTH LLCITS2026-04-27
00810178884759CoreTechVIVE HEALTH LLCITS2026-04-27
00810113683515ManaEZ Hip Ice CureTechManamed, Inc.ITS2025-10-03
00810060887394Rhino MD ORTHOPAEDICS, INC.ITS2024-10-29
00810060887400Rhino MD ORTHOPAEDICS, INC.ITS2024-10-29
08809642990272QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990289QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990296QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990302QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990319QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990326QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990333QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990340QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990357QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990364QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990005QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990012QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990029QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990036QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990043QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990050QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990067QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990074QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990081QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990098QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990104QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990111QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990128QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990135QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990142QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01