SilhouetteStar

GUDID 09420071400010

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.

ARANZ MEDICAL LIMITED

Wound measure Wound measure Wound measure Wound measure Wound measure Wound measure Wound measure Wound measure Wound measure Wound measure Wound measure Wound measure Wound measure Wound measure Wound measure Wound measure Wound measure
Primary Device ID09420071400010
NIH Device Record Key58c09bac-ef1c-47b9-aebd-1b1108c36bcc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilhouetteStar
Version Model Number2005.01
Company DUNS593280170
Company NameARANZ MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com
Phone+1 8664670934
Emailsupport@aranzmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS109420071400010 [Primary]

FDA Product Code

FXNTape, Camera, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-11
Device Publish Date2024-04-03

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