RapidSorb 85163501S
GUDID H98085163501S0
1.5MM RAPID RESORB CONTOURABLE MESH 20X30X.25MM THICK-STERIL
SYNTHES (U.S.A.) LP
Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable| 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 |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10887587063997 [Primary] |
| HIBCC | H98085163501S0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062789
FDA Product Code
| JEY | PLATE, BONE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [RapidSorb]
| 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 |
Trademark Results [RapidSorb]
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 |
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