RapidSorb 85163501S

GUDID H98085163501S0

1.5MM RAPID RESORB CONTOURABLE MESH 20X30X.25MM THICK-STERIL

SYNTHES (U.S.A.) LP

Orthopaedic fixation plate, bioabsorbable
Primary Device IDH98085163501S0
NIH Device Record Keya3929b82-19dd-4adb-82bf-5a3189d3abe3
Commercial Distribution StatusIn Commercial Distribution
Brand NameRapidSorb
Version Model Number851.635.01S
Catalog Number85163501S
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 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *.
Handling Environment TemperatureBetween 0 and 43 Degrees Celsius
Handling Environment TemperatureBetween 0 and 110 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587063997 [Primary]
HIBCCH98085163501S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, 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 [RapidSorb]

H98080604802S02.5MM RAPID RESORBABLE EMERGENCY SCREW 8MM-STERILE
H98080604602S02.5MM RAPID RESORBABLE EMERGENCY SCREW 6MM-STERILE
H98080604402S02.5MM RAPID RESORBABLE EMERGENCY SCREW 4MM-STERILE
H98080600804S02.0MM RAPID RESORBABLE CORTEX SCREW 8MM-STERILE
H98080600802S02.0MM RAPID RESORBABLE CORTEX SCREW 8MM-STERILE
H98080600610S02.0MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE
H98080600604S02.0MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE
H98080600602S02.0MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE
H98080600410S02.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
H98080600404S02.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
H98080600402S02.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
H98080560804S01.5MM RAPID RESORBABLE CORTEX SCREW 8MM-STERILE
H98080560802S01.5MM RAPID RESORBABLE CORTEX SCREW 8MM-STERILE
H98080560610S01.5MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE
H98080560604S01.5MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE
H98080560602S01.5MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE
H98080560510S01.5MM RAPID RESORBABLE CORTEX SCREW 5MM-STERILE
H98080560504S01.5MM RAPID RESORBABLE CORTEX SCREW 5MM-STERILE
H98080560502S01.5MM RAPID RESORBABLE CORTEX SCREW 5MM-STERILE
H98080560420S01.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
H98080560410S01.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
H98080560404S01.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
H98080560402S01.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
H98080560320S01.5MM RAPID RESORBABLE CORTEX SCREW 3MM-STERILE
H98080560310S01.5MM RAPID RESORBABLE CORTEX SCREW 3MM-STERILE
H98080560304S01.5MM RAPID RESORBABLE CORTEX SCREW 3MM-STERILE
H98080560302S01.5MM RAPID RESORBABLE CORTEX SCREW 3MM-STERILE
108875870727601.7MM DRILL BIT WITH 8MM STOP J-LATCH F/RAPIDSORB IPS-STER
108875870727531.7MM DRILL BIT WITH 7MM STOP J-LATCH F/RAPIDSORB IPS-STER
108875870727461.7MM DRILL BIT WITH 6MM STOP J-LATCH F/RAPIDSORB IPS-STER
108875870727391.7MM DRILL BIT WITH 5MM STOP J-LATCH F/RAPIDSORB IPS-STER
108875870727221.7MM DRILL BIT WITH 4MM STOP J-LATCH F/RAPIDSORB IPS-STER
108875870727151.7MM DRILL BIT WITH 3MM STOP J-LATCH F/RAPIDSORB IPS-STER
H98053055501S0RAPIDSORB IPS DELIVERY DEVICE REPLACEMENT CAP-STERILE
H98085264101S02.0MM RAPID RESORB CONTOURABLE MESH 50MM DIA/1.2MM THK-STER
H98085252101S02.0MM RAPID RESORBABLE MESH 78MMX78MMX1.2MM-STERILE
H98085252001S02.0MM RAPID RESORBABLE MESH 48MMX48MMX1.2MM-STERILE
H98085242101S02.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX18 HOLES-STERILE
H98085242001S02.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX10 HOLES-STERILE
H98085234301S02.0MM RAPID RESORBABLE Y-PLATE 4X3X3 HOLES-STERILE
H98085226401S02.0MM RAPID RESORBABLE OBLIQUE L-PLATE 6H X 4H/RIGHT-STERILE
H98085226301S02.0MM RAPID RESORBABLE OBLIQUE L-PLATE 6H X 4H/LEFT-STERILE
H98085211001S02.0MM RAPID RESORBABLE ORBITAL RIM PLATE 10 HOLES-STERILE
H98085202001S02.0MM RAPID RESORB ADAPTION PLATE 20 HOLES-STERILE
H98085200801S02.0MM RAPID RESORBABLE ADAPTION PLATE 8 HOLES-STERILE
H98085200401S02.0MM RAPID RESORBABLE STRAIGHT PLATE 4 HOLES-STERILE
H98085200201S02.0MM RAPID RESORBABLE STRAIGHT PLATE 2 HOLES-STERILE
H98085180101S0RAPID RESORBABLE CRANIAL CLAMP 18MM
H98085172401S01.5MM RAPID RESORB STRAIGHT ROW MESH/75X75X0.8MM THK-STER
H98085172201S01.5MM RAPID RESORB STRAIGHT ROW MESH 100X100X0.8MM-STERILE

Trademark Results [RapidSorb]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RAPIDSORB
RAPIDSORB
98090088 not registered Live/Pending
W.F. Young, Inc.
2023-07-18
RAPIDSORB
RAPIDSORB
78760069 3396084 Live/Registered
DEPUY SYNTHES, INC.
2005-11-23
RAPIDSORB
RAPIDSORB
73809499 1586426 Live/Registered
E. T. BROWNE DRUG CO., INC.
1989-06-28

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