STARlight® 764.03A

GUDID B15176403A0

The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on inf

ORTHOMERICA PRODUCTS, INC.

Cranial orthosis Cranial orthosis

• Primary Device ID: B15176403A0
• NIH Device Record Key: a2ee6164-ac83-4697-86ff-dcfaa02dbf78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARlight®
• Version Model Number: 764.03A
• Catalog Number: 764.03A
• 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	B15176403A0 [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 [STARlight®]

• B15176503PA0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15176503A0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15176403PA0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15176403A0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15176303PA0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15176303A0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15176203PA0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15176203A0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15176103PA0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15176103A0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15176003PA0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15176003A0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15170903PA0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15170903A0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15170403PA0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15170403A0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15170303PA0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15170303A0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15176603PA0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve
• B15176603A0: The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve