Scar Fx 11012

GUDID 00642790110127

Scar Fx Silicone Sheeting 10"x12"

Scar Heal

Scar management dressing, reusable
Primary Device ID00642790110127
NIH Device Record Key13f96b83-9204-4b48-8908-ab96170b3675
Commercial Distribution StatusIn Commercial Distribution
Brand NameScar Fx
Version Model Number11012
Catalog Number11012
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 Usefalse
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

Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch
Height10 Inch
Width12 Inch

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
GS100642790110127 [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 [Scar Fx]

00642790156781Scar Fx Silicone Sheeting Breast Anchor
00642790134567Scar Fx Silicone Sheeting Lollipop Breast Piece
00642790115092Scar Fx Silicone Sheeting 1.5"x9"
00642790115054Scar Fx Silicone Sheeting 1.5"x5"
00642790115030Scar Fx Silicone Sheeting 1.5"x3"
00642790112343Scar Fx Silicone Sheeting Breast Piece
00642790110127Scar Fx Silicone Sheeting 10"x12"
00642790106489Gelzone garment belt with silicone sheeting 6"x48"
00642790104089Scar Fx Silicone Sheeting 4"x8"
00642790103051Scar Fx Silicone Sheeting 3"x5"
00642790101224Scar Fx Silicone Sheeting 1"x22"
00642790101125Scar Fx Silicone Sheeting 1"x12"
00642790100005Scar Fx Silicone Sheeting 3" Breast Circle
00642790101019Scar Fx Silicone Sheeting 1"x1"

Trademark Results [Scar Fx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SCAR FX
SCAR FX
75332421 2304593 Live/Registered
ATLANTIC MEDICAL PRODUCTS LLC
1997-07-29

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