Rhino

Basic Information

• Brand Name: Rhino
• Primary DI: 00810060887516
• Version / Model: Pavlik Harness Blue - Extra Small
• Catalog Number: 27161
• Company Name: MD ORTHOPAEDICS, INC.
• Labeler DUNS: 146220269
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-20
• Public Version: 1
• Public Version Date: 2023-12-28
• Public Version Status: New
• Public Device Record Key: 3246dec0-a5fd-487c-8040-91de5502d5d9

Device Description

Pavlik Harness Blue - Extra Small

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITS	Joint, Hip, External Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65483	Infant hip harness	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810060887516	GS1