Michigan Cranial Reshaping Orthosis

GUDID 00862948000302

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.

DANMAR PRODUCTS INC

Cranial orthosis

• Primary Device ID: 00862948000302
• NIH Device Record Key: d2218c71-99d9-4e29-8a06-06fe4e778ee5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Michigan Cranial Reshaping Orthosis
• Version Model Number: 9841
• Company DUNS: 041113952
• Company Name: DANMAR PRODUCTS INC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)783-1998
• Email: sales@danmarproducts.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862948000302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003630

FDA Product Code

• OAN: Orthosis, Cranial, Laser Scan

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-23