STARlight® Bi-Valve 765.01A

GUDID B15176501A0

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

ORTHOMERICA PRODUCTS, INC.

Cranial orthosis

• Primary Device ID: B15176501A0
• NIH Device Record Key: 2280e4a5-248d-4842-8345-3b7f05242509
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARlight® Bi-Valve
• Version Model Number: 765.01A
• Catalog Number: 765.01A
• 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	B15176501A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151979

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 [STARlight® Bi-Valve]

• B15176501PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176501A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176401PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176401A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176301PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176301A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176201PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176201A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176101PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176101A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176001PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176001A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15170901PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15170901A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15170401PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15170401A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15170301PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15170301A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176601PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176601A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t