RejuvaSil 80015

GUDID 00642790800158

RejuvaSil Silicone Scar Gel 15 ml

Scar Heal

Scar management dressing, single-use, non-sterile
Primary Device ID00642790800158
NIH Device Record Keyf6b418f6-3b5a-40c6-be72-baf37ffc9023
Commercial Distribution StatusIn Commercial Distribution
Brand NameRejuvaSil
Version Model Number80015
Catalog Number80015
Company DUNS014302733
Company NameScar Heal
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 Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com
Phone727-535-0022
Emailhello@rejuvaskin.com

Device Dimensions

Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100642790800158 [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 Date2020-08-10
Device Publish Date2020-07-31

On-Brand Devices [RejuvaSil]

00642790800158RejuvaSil Silicone Scar Gel 15 ml
00642790800103RejuvaSil Silicone Scar Gel 10 ml
00642790800004RejuvaSil Silicone Scar Gel 30 ml

Trademark Results [RejuvaSil]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REJUVASIL
REJUVASIL
77374991 3535215 Live/Registered
ATLANTIC MEDICAL PRODUCTS LLC
2008-01-18

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.