AccessGUDID - DEVICE: STARscanner (B590507012000)

GUDID

Device Identifier (DI) Information

Brand Name: STARscanner
Version or Model: Series B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50-7012-00
Company Name: Vorum Research Corporation

Primary DI Number: B590507012000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 249800053 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62265	Cranial orthosis	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAN	Orthosis, Cranial, Laser Scan

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ded3a5ca-7f9b-4eeb-b36d-f5651c4cbf5f
Public Version Date: March 10, 2021
Public Version Number: 1
DI Record Publish Date: March 02, 2021