Clarren Helmet 709.05A

GUDID B15170905A0

The Clarren Helmet is a patient specific cranial orthosis that applies passive pressure to prominent regions of an infant’s cranium in order to improv

ORTHOMERICA PRODUCTS, INC.

Cranial orthosis

• Primary Device ID: B15170905A0
• NIH Device Record Key: 77763039-c147-4a3c-a058-5cdb50e905d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarren Helmet
• Version Model Number: 709.05A
• Catalog Number: 709.05A
• Company DUNS: 604405373
• Company Name: ORTHOMERICA PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• 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: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B15170905A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021918

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: 2016-08-23

On-Brand Devices [Clarren Helmet]

• B15170905A0: The Clarren Helmet is a patient specific cranial orthosis that applies passive pressure to promi
• B15170405A0: The Clarren Helmet is a patient specific cranial orthosis that applies passive pressure to promi
• B15170305A0: The Clarren Helmet is a patient specific cranial orthosis that applies passive pressure to promi