PRO-SIL PROK-111

GUDID 00852260000173

Pro-Sil Kids 4.25g

BIODERMIS CORPORATION

Scar management dressing, reusable
Primary Device ID00852260000173
NIH Device Record Keyafd89a1e-2646-4f0f-9d9d-4584df498f84
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRO-SIL
Version Model NumberPROK-111
Catalog NumberPROK-111
Company DUNS809650005
Company NameBIODERMIS CORPORATION
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 Usetrue
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

Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 55 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100852260000173 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-04
Device Publish Date2020-08-27

On-Brand Devices [PRO-SIL]

00852260000999PRO-SIL 4.25g Tube
00852260000296Pro-Sil SPF 15 17g
00852260000289Pro-Sil SPF 15 4.25g
00852260000173Pro-Sil Kids 4.25g
00852260000166Pro-Sil 17g
00852260000159Pro-Sil 4.25g

Trademark Results [PRO-SIL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRO-SIL
PRO-SIL
86733221 5024015 Live/Registered
Bull Bond Manufacturing Corp.
2015-08-21
PRO-SIL
PRO-SIL
86593328 not registered Dead/Abandoned
Lukos Enterprises, LLC
2015-04-10
PRO-SIL
PRO-SIL
79045383 3534286 Live/Registered
Infineon Technologies AG
2007-09-11
PRO-SIL
PRO-SIL
78465469 3086529 Live/Registered
BIODERMIS CORPORATION
2004-08-11

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