SilhouetteStar

Basic Information

• Brand Name: SilhouetteStar
• Primary DI: 09420071400010
• Version / Model: 2005.01
• Company Name: ARANZ MEDICAL LIMITED
• Labeler DUNS: 593280170
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-03
• Public Version: 1
• Public Version Date: 2024-04-11
• Public Version Status: New
• Public Device Record Key: 58c09bac-ef1c-47b9-aebd-1b1108c36bcc

Device Description

SilhouetteStar™ is a non-contact device used to collect images, measurements and other information from all external wound types at the point of care; it is connected to a computer via a USB cable.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FXN	Tape, Camera, Surgical	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44866	Wound measure	A device designed to determine the dimensions of a wound typically to document changes in wound size during the healing process. The device may be a simple ruler or similar measuring device and/or a tracing film to outline a wound that may utilize an electronic digital tablet to calculate wound area or other dimensions (e.g., length, width, depth). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09420071400010	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]