FDA.reportPublic FDA data

STARscanner

Primary DI
B590507012000
Brand
STARscanner
Company
Vorum Research Corporation
Model
Series B
Catalog number
50-7012-00
Device description
Eye-Safe Laser Data Acquisition System that collects 3-D infant’s head shape data which is used for the fabrication of cranial orthoses.
Published
2021-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OANOrthosis, Cranial, Laser Scan

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OANOrthosis, Cranial, Laser ScanNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B590507012000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cranial orthosisA custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. It is made of durable materials (e.g., plastic, solid foam) and is designed with patient-specific characteristics (e.g., size, shape) based on head measurements (e.g., clinical pictures, 3-D scans, casts). It is typically worn during daily activities and sleep. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
16043217277support@vorum.com

Regulatory Flags#

DUNS number
249800053
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00860015811110Talee PostOpINVENT MEDICAL USA LLCOAN2026-04-28
00860013026103Doc Band®Cranial Technologies, Inc.OAN2026-03-04
00860013026110Doc Band®Cranial Technologies, Inc.OAN2026-03-04
00860013898007TaleeINVENT MEDICAL USA LLCOAN2025-05-12
00860013898014TaleeINVENT MEDICAL USA LLCOAN2025-05-12
00860013898021TaleeINVENT MEDICAL USA LLCOAN2025-05-12
00860013898038TaleeINVENT MEDICAL USA LLCOAN2025-05-12
00860013898045Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00860013898052Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00860013898069Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00860013898076Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
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