OrthoMesh 80360502S

GUDID H67980360502S0

1.5MM RESORBABLE CORTEX SCREW 5MM FOR ORTHOMESH-STERILE

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, bioabsorbable
Primary Device IDH67980360502S0
NIH Device Record Key312cc5db-569f-4aeb-9441-634783eee853
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoMesh
Version Model Number803.605.02S
Catalog Number80360502S
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count2
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
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
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 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS120886982255935 [Primary]
GS180886982255937 [Unit of Use]
HIBCCH67980360502S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

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 [OrthoMesh]

H67980400602S02.0MM RESORBABLE CORTEX SCREW 6MM FOR ORTHOMESH-STERILE
H67980360502S01.5MM RESORBABLE CORTEX SCREW 5MM FOR ORTHOMESH-STERILE

Trademark Results [OrthoMesh]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORTHOMESH
ORTHOMESH
77717635 3759211 Live/Registered
DEPUY SYNTHES, INC.
2009-04-20

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