Rystora Silicone Scar Gel

GUDID 04711182608156

FORTUNE MEDICAL INSTRUMENT CORP.

Scar management dressing, reusable
Primary Device ID04711182608156
NIH Device Record Key495f9404-5b43-4d22-8d18-05d566b4a539
Commercial Distribution StatusIn Commercial Distribution
Brand NameRystora Silicone Scar Gel
Version Model NumberSGA01501
Company DUNS656763489
Company NameFORTUNE MEDICAL INSTRUMENT CORP.
Device Count24
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS104711182608156 [Unit of Use]
GS114711182608153 [Primary]

FDA Product Code

PFPSilicone Hydrogel 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 Date2022-01-07
Device Publish Date2021-12-30

Devices Manufactured by FORTUNE MEDICAL INSTRUMENT CORP.

14711182608306 - Silicone T Drainage Set With Eyes2023-11-01
14711182608313 - Silicone T Drainage Set With Eyes2023-11-01
04711182608163 - Rystora Skin Protector-Spray2022-02-08
04710961934844 - Silicone C.W.V. Reservoir2022-02-08
04710961934851 - Silicone C.W.V. Reservoir2022-02-08
04710961934868 - Silicone C.W.V. Reservoir2022-02-08
04710961934875 - Silicone C.W.V. Reservoir (Top Outlet)2022-02-08
04710961934882 - Silicone C.W.V. Reservoir2022-02-08

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