Primary Device ID | H98085163501S0 |
NIH Device Record Key | a3929b82-19dd-4adb-82bf-5a3189d3abe3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RapidSorb |
Version Model Number | 851.635.01S |
Catalog Number | 85163501S |
Company DUNS | 832637081 |
Company Name | SYNTHES (U.S.A.) LP |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Handling Environment Temperature | Between 0 and 110 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10887587063997 [Primary] |
HIBCC | H98085163501S0 [Secondary] |
JEY | PLATE, BONE |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-09-14 |
H98080604802S0 | 2.5MM RAPID RESORBABLE EMERGENCY SCREW 8MM-STERILE |
H98080604602S0 | 2.5MM RAPID RESORBABLE EMERGENCY SCREW 6MM-STERILE |
H98080604402S0 | 2.5MM RAPID RESORBABLE EMERGENCY SCREW 4MM-STERILE |
H98080600804S0 | 2.0MM RAPID RESORBABLE CORTEX SCREW 8MM-STERILE |
H98080600802S0 | 2.0MM RAPID RESORBABLE CORTEX SCREW 8MM-STERILE |
H98080600610S0 | 2.0MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE |
H98080600604S0 | 2.0MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE |
H98080600602S0 | 2.0MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE |
H98080600410S0 | 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE |
H98080600404S0 | 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE |
H98080600402S0 | 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE |
H98080560804S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 8MM-STERILE |
H98080560802S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 8MM-STERILE |
H98080560610S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE |
H98080560604S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE |
H98080560602S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE |
H98080560510S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 5MM-STERILE |
H98080560504S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 5MM-STERILE |
H98080560502S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 5MM-STERILE |
H98080560420S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE |
H98080560410S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE |
H98080560404S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE |
H98080560402S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE |
H98080560320S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 3MM-STERILE |
H98080560310S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 3MM-STERILE |
H98080560304S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 3MM-STERILE |
H98080560302S0 | 1.5MM RAPID RESORBABLE CORTEX SCREW 3MM-STERILE |
10887587072760 | 1.7MM DRILL BIT WITH 8MM STOP J-LATCH F/RAPIDSORB IPS-STER |
10887587072753 | 1.7MM DRILL BIT WITH 7MM STOP J-LATCH F/RAPIDSORB IPS-STER |
10887587072746 | 1.7MM DRILL BIT WITH 6MM STOP J-LATCH F/RAPIDSORB IPS-STER |
10887587072739 | 1.7MM DRILL BIT WITH 5MM STOP J-LATCH F/RAPIDSORB IPS-STER |
10887587072722 | 1.7MM DRILL BIT WITH 4MM STOP J-LATCH F/RAPIDSORB IPS-STER |
10887587072715 | 1.7MM DRILL BIT WITH 3MM STOP J-LATCH F/RAPIDSORB IPS-STER |
H98053055501S0 | RAPIDSORB IPS DELIVERY DEVICE REPLACEMENT CAP-STERILE |
H98085264101S0 | 2.0MM RAPID RESORB CONTOURABLE MESH 50MM DIA/1.2MM THK-STER |
H98085252101S0 | 2.0MM RAPID RESORBABLE MESH 78MMX78MMX1.2MM-STERILE |
H98085252001S0 | 2.0MM RAPID RESORBABLE MESH 48MMX48MMX1.2MM-STERILE |
H98085242101S0 | 2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX18 HOLES-STERILE |
H98085242001S0 | 2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX10 HOLES-STERILE |
H98085234301S0 | 2.0MM RAPID RESORBABLE Y-PLATE 4X3X3 HOLES-STERILE |
H98085226401S0 | 2.0MM RAPID RESORBABLE OBLIQUE L-PLATE 6H X 4H/RIGHT-STERILE |
H98085226301S0 | 2.0MM RAPID RESORBABLE OBLIQUE L-PLATE 6H X 4H/LEFT-STERILE |
H98085211001S0 | 2.0MM RAPID RESORBABLE ORBITAL RIM PLATE 10 HOLES-STERILE |
H98085202001S0 | 2.0MM RAPID RESORB ADAPTION PLATE 20 HOLES-STERILE |
H98085200801S0 | 2.0MM RAPID RESORBABLE ADAPTION PLATE 8 HOLES-STERILE |
H98085200401S0 | 2.0MM RAPID RESORBABLE STRAIGHT PLATE 4 HOLES-STERILE |
H98085200201S0 | 2.0MM RAPID RESORBABLE STRAIGHT PLATE 2 HOLES-STERILE |
H98085180101S0 | RAPID RESORBABLE CRANIAL CLAMP 18MM |
H98085172401S0 | 1.5MM RAPID RESORB STRAIGHT ROW MESH/75X75X0.8MM THK-STER |
H98085172201S0 | 1.5MM RAPID RESORB STRAIGHT ROW MESH 100X100X0.8MM-STERILE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RAPIDSORB 98090088 not registered Live/Pending |
W.F. Young, Inc. 2023-07-18 |
RAPIDSORB 78760069 3396084 Live/Registered |
DEPUY SYNTHES, INC. 2005-11-23 |
RAPIDSORB 73809499 1586426 Live/Registered |
E. T. BROWNE DRUG CO., INC. 1989-06-28 |