STARband® 764A

GUDID B151764A0

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

ORTHOMERICA PRODUCTS, INC.

Cranial orthosis

• Primary Device ID: B151764A0
• NIH Device Record Key: e94e91cf-4325-4a36-b978-6bd9ea55eb54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARband®
• Version Model Number: 764A
• Catalog Number: 764A
• 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	B151764A0 [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®]

• B151765PA0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151765A0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151764PA0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151764A0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151763PA0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151763A0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151762PA0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151762A0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151761PA0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151761A0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151760PA0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151760A0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151709PA0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151709A0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151704PA0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151704A0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151703PA0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151703A0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151766PA0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve
• B151766A0: The STARband® is a patient specific cranial orthosis that redirects the head growth to improve