STARscanner 50-7012-00

GUDID B590507012000

Eye-Safe Laser Data Acquisition System that collects 3-D infant’s head shape data which is used for the fabrication of cranial orthoses.

Vorum Research Corporation

Cranial orthosis

• Primary Device ID: B590507012000
• NIH Device Record Key: ded3a5ca-7f9b-4eeb-b36d-f5651c4cbf5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARscanner
• Version Model Number: Series B
• Catalog Number: 50-7012-00
• Company DUNS: 249800053
• Company Name: Vorum Research Corporation
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 16043217277
• Email: support@vorum.com
• Phone: 16043217277
• Email: support@vorum.com
• Phone: 16043217277
• Email: support@vorum.com
• Phone: 16043217277
• Email: support@vorum.com
• Phone: 16043217277
• Email: support@vorum.com
• Phone: 16043217277
• Email: support@vorum.com
• Phone: 16043217277
• Email: support@vorum.com
• Phone: 16043217277
• Email: support@vorum.com
• Phone: 16043217277
• Email: support@vorum.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B590507012000 [Primary]

FDA Product Code

• OAN: Orthosis, Cranial, Laser Scan

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-10
• Device Publish Date: 2021-03-02