FDA.reportPublic FDA data

Rhino

Primary DI
00810060888100
Brand
Rhino
Company
MD ORTHOPAEDICS, INC.
Model
Leg Strap Pink - Preemie
Catalog number
27350
Device description
Leg Strap Pink - Preemie
Published
2024-01-02
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
00810060888100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060888100008100608881008100608881000810060888100

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.

Sterilization Methods#

Method table
Method

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
00810178883127ViveVIVE HEALTH LLCIQI2026-07-21
00810178883134ViveVIVE HEALTH LLCIQI2026-07-21
00810178883141ViveVIVE HEALTH LLCIQI2026-07-21
00810178883158ViveVIVE HEALTH LLCIQI2026-07-21
00400000326986MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000326993MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327006MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327013MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327020MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327037MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327044MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327051MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327068MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327075MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327082MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327099MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327105MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327112MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327129MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327136MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327143MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327150MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327167MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327174MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327181MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327198MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327204MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327211MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327228MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327235MEDIMEDI MANUFACTURING, INC.IQI2026-07-20