Michigan Cranial Reshaping Orthosis

Basic Information

• Brand Name: Michigan Cranial Reshaping Orthosis
• Primary DI: 00862948000302
• Version / Model: 9841
• Company Name: DANMAR PRODUCTS INC
• Labeler DUNS: 041113952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d2218c71-99d9-4e29-8a06-06fe4e778ee5

Device Description

The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic-shaped heads.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
OAN	Orthosis, Cranial, Laser Scan	Neurology	882.5970	2
MVA	Orthosis, Cranial	Neurology	882.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62265	Cranial orthosis	A custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. It is made of durable materials (e.g., plastic, solid foam) and is designed with patient-specific characteristics (e.g., size, shape) based on head measurements (e.g., clinical pictures, 3-D scans, casts). It is typically worn during daily activities and sleep. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00862948000302	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K003630	000
K090341	000