STARlight® PRO 764.07PA

GUDID B15176407PA0

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

ORTHOMERICA PRODUCTS, INC.

Cranial orthosis

• Primary Device ID: B15176407PA0
• NIH Device Record Key: cea7e373-be94-4444-82d5-677052f7cca8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARlight® PRO
• Version Model Number: 764.07PA
• Catalog Number: 764.07PA
• 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	B15176407PA0 [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® PRO]

• B15176507PA0: The STARlight® PRO is a patient specific cranial orthosis that redirects the head growth to imp
• B15176407PA0: The STARlight® PRO is a patient specific cranial orthosis that redirects the head growth to imp
• B15176307PA0: The STARlight® PRO is a patient specific cranial orthosis that redirects the head growth to imp
• B15176207PA0: The STARlight® PRO is a patient specific cranial orthosis that redirects the head growth to imp
• B15176107PA0: The STARlight® PRO is a patient specific cranial orthosis that redirects the head growth to imp
• B15176007PA0: The STARlight® PRO is a patient specific cranial orthosis that redirects the head growth to imp
• B15170907PA0: The STARlight® PRO is a patient specific cranial orthosis that redirects the head growth to imp
• B15170407PA0: The STARlight® PRO is a patient specific cranial orthosis that redirects the head growth to imp
• B15170307PA0: The STARlight® PRO is a patient specific cranial orthosis that redirects the head growth to imp
• B15176607PA0: The STARlight® PRO is a patient specific cranial orthosis that redirects the head growth to imp