RapidSorb 310405S

GUDID 10887587072739

1.7MM DRILL BIT WITH 5MM STOP J-LATCH F/RAPIDSORB IPS-STER

SYNTHES (U.S.A.) LP

Fluted surgical drill bit, reusable

• Primary Device ID: 10887587072739
• NIH Device Record Key: bb6df91a-97df-4ef2-80ce-454f9d83c651
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RapidSorb
• Version Model Number: 310.405S
• Catalog Number: 310405S
• 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
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587072739 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043310

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• 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