STARband® Bi-Valve 764.06A

GUDID B15176406A0

The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for us

ORTHOMERICA PRODUCTS, INC.

Cranial orthosis

• Primary Device ID: B15176406A0
• NIH Device Record Key: 75f641c9-a71c-4ae9-a5a6-1e9c0ec3459d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARband® Bi-Valve
• Version Model Number: 764.06A
• Catalog Number: 764.06A
• 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	B15176406A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151147

FDA Product Code

• MVA: Orthosis, Cranial

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 [STARband® Bi-Valve]

• B15176506PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176506A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176406PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176406A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176306PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176306A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176206PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176206A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176106PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176106A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176006PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176006A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15170906PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15170906A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15170406PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15170406A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15170306PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15170306A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176606PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176606A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to