Cimeosil® Scar and Laser Gel CSG-14

GUDID M724CSG141

Scar and Laser Gel

IMPLANTECH ASSOCIATES, INC.

Scar management dressing, reusable
Primary Device IDM724CSG141
NIH Device Record Keyb2b6ab5a-5411-44de-aa9a-4b2ca69ad842
Commercial Distribution StatusIn Commercial Distribution
Brand NameCimeosil® Scar and Laser Gel
Version Model Number14 gram
Catalog NumberCSG-14
Company DUNS784664955
Company NameIMPLANTECH ASSOCIATES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 16 Degrees Celsius and 29 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM724CSG141 [Primary]
HIBCCM724CSG1412PK2 [Package]
Package: Box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDAElastomer, Silicone, For Scar Management

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-11-17
Device Publish Date2020-05-27

On-Brand Devices [Cimeosil® Scar and Laser Gel]

M724CSG141Scar and Laser Gel
M724CSG051Scar and Laser Gel

Trademark Results [Cimeosil]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CIMEOSIL
CIMEOSIL
76074984 2724924 Live/Registered
IMPLANTECH ASSOCIATES, INC.
2000-06-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.