CRANIOS Reinforced 6160301S

GUDID H9806160301S0

CRANIOS REINFORCED ROTARY MIX 3CC-STERILE

SYNTHES (U.S.A.) LP

Bone matrix implant, synthetic
Primary Device IDH9806160301S0
NIH Device Record Key6e17f5c4-3b85-439c-8d6f-91eac128933a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRANIOS Reinforced
Version Model Number616.03.01S
Catalog Number6160301S
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
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 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
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

Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *.

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587058672 [Primary]
HIBCCH9806160301S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXPMETHYL METHACRYLATE FOR CRANIOPLASTY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-14

On-Brand Devices [CRANIOS Reinforced]

H9806161001S0CRANIOS REINFORCED ROTARY MIX 10CC-STERILE
H9806160501S0CRANIOS REINFORCED ROTARY MIX 5CC-STERILE
H9806160301S0CRANIOS REINFORCED ROTARY MIX 3CC-STERILE
H9806151001S0CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE
H9806150501S0CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE
H9806150301S0CRANIOS REINFORCED FAST SET PUTTY 3CC-STERILE

Trademark Results [CRANIOS Reinforced]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CRANIOS REINFORCED
CRANIOS REINFORCED
85186089 4250595 Live/Registered
DEPUY SYNTHES, INC.
2010-11-29

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