Rystora® Scar Sheets

GUDID 14711182628779

FORTUNE MEDICAL INSTRUMENT CORP.

Scar management dressing, reusable
Primary Device ID14711182628779
NIH Device Record Key131ecf6d-d24d-4143-9781-8b2fe27fba6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRystora® Scar Sheets
Version Model NumberSA042501
Company DUNS656763489
Company NameFORTUNE MEDICAL INSTRUMENT CORP.
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS114711182628779 [Primary]

FDA Product Code

MDAElastomer, Silicone, For Scar Management

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-02
Device Publish Date2021-11-24

On-Brand Devices [Rystora® Scar Sheets]

14711182628779SA042501
04711182607029SA101812
04711182607012SA050712
04711182607005SA042512
14711182628762SA050701
14711182628755SA101801

Trademark Results [Rystora]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RYSTORA
RYSTORA
85132940 4150899 Live/Registered
FORTUNE MEDICAL INSTRUMENT CORP.
2010-09-19

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