RapidSorb 80551001S
GUDID H98080551001S0
RAPIDSORB IPS 1.5MM FASTENER CARTRIDGE/MEDIUM-STERILE
SYNTHES (U.S.A.) LP
Craniofacial bone tack, bioabsorbable| Primary Device ID | H98080551001S0 |
| NIH Device Record Key | e34a66b4-b25e-4bda-928a-30dd53682f40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RapidSorb |
| Version Model Number | 805.510.01S |
| Catalog Number | 80551001S |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| 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 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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Operating and Storage Conditions
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between -55 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10887587061580 [Primary] |
| HIBCC | H98080551001S0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141385
FDA Product Code
| HBW | FASTENER, PLATE, CRANIOPLASTY |
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 | 2016-10-07 |
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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