SyntheCel SC40012001S

GUDID H980SC40012001S0

SYNTHECEL® DURA REPAIR 10.0CM X 12.0CM(4" X5")STERILE

SYNTHES (U.S.A.) LP

Dura mater graft, bioengineered
Primary Device IDH980SC40012001S0
NIH Device Record Key0fae0d2f-49bf-42a0-8671-77eac70831ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameSyntheCel
Version Model NumberSC.400.120.01S
Catalog NumberSC40012001S
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from heat and radio- active sources
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587001395 [Primary]
HIBCCH980SC40012001S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXQDURA SUBSTITUTE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-06
Device Publish Date2015-09-14

On-Brand Devices [SyntheCel]

H980SC40012001S0SYNTHECEL® DURA REPAIR 10.0CM X 12.0CM(4" X5")STERILE
H980SC40005601S0SYNTHECEL® DURA REPAIR 7.5CM X 7.5CM(3" X 3")STERILE
H980SC40002501S0SYNTHECEL® DURA REPAIR 5.0CM X 5.0CM(2" X 2")STERILE
H980SC40001901S0SYNTHECEL® DURA REPAIR 2.5CM X 7.5CM(1" X 3")STERILE
H980SC40000601S0SYNTHECEL® DURA REPAIR 2.5CM X 2.5CM(1" X 1")STERILE
10887587076669SYNTHECEL® DURA REPAIR 14CM X 20CM (5.5"X 8") STER

Trademark Results [SyntheCel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYNTHECEL
SYNTHECEL
77722813 3701709 Live/Registered
DEPUY SYNTHES, INC.
2009-04-27

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