OSCAR 3 OHP2100SU

GUDID 18056099649773

SINGLE USE 10MM PIERCER PROBE – STERILE

ORTHOFIX SRL

Hard-tissue ultrasonic surgical system

• Primary Device ID: 18056099649773
• NIH Device Record Key: 5e8312e1-7b89-4534-a10a-5d05d8995b1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSCAR 3
• Version Model Number: 1
• Catalog Number: OHP2100SU
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• 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: true
• 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: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it

Device Dimensions

• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18056099649773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093805

FDA Product Code

• LZV: System, Cement Removal Extraction

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: 2018-07-24
• Device Publish Date: 2017-09-18

On-Brand Devices [OSCAR 3]

• 18056099649995: BONECUTTER OSTEOTOME HANDSET
• 18056099649988: CEMENT REMOVAL HANDSET
• 18056099649971: ULTRASONIC GENERATOR 230V CE
• 18056099649964: LONG EXTENSION REDUCER BAR FOR SINGLE USE PROBES
• 18056099649957: SHORT EXTENSION REDUCER BAR FOR SINGLE USE PROBES
• 18056099649940: SINGLE USE LONG EXTENSION REDUCER BAR – STERILE
• 18056099649933: SINGLE USE SHORT EXTENSION REDUCER BAR – STERILE
• 18056099649926: SINGLE USE 2 LOBED GROOVER PROBE – STERILE
• 18056099649919: SINGLE USE FLAT PIERCER PROBE – STERILE
• 18056099649902: REDUCER BAR FOR OHP218FSU
• 18056099649896: SINGLE USE 8MM HOE PROBE – STERILE
• 18056099649889: SINGLE USE 6MM HOE PROBE - 180MM – STERILE
• 18056099649872: SINGLE USE 6MM SERRATED CURVED OSTEOTOME – STERILE
• 18056099649865: SINGLE USE 6MM FLAT OSTEOTOME – STERILE
• 18056099649858: SINGLE USE 6MM SERRATED OSTEOTOME – STERILE
• 18056099649841: SINGLE USE ACETABULAR PROBE – STERILE
• 18056099649834: SINGLE USE EXTRACTION PROBE FOR SLAPHAMMER – STERILE
• 18056099649827: SLAPHAMMER (CONSUMABLE)
• 18056099649810: SINGLE USE 6MM SCRAPER PROBE - SLIM - 180MM – STERILE
• 18056099649803: SINGLE USE 6MM PIERCER PROBE - SLIM - 180MM – STERILE
• 18056099649797: SINGLE USE 10MM SCRAPER PROBE - 80MM – STERILE
• 18056099649780: SINGLE USE 8MM SCRAPER PROBE - 80MM – STERILE
• 18056099649773: SINGLE USE 10MM PIERCER PROBE – STERILE
• 18056099649766: SINGLE USE 8MM PIERCER PROBE – STERILE
• 18056099649759: BONECUTTER - EXTENSION BAR
• 18056099649742: EXTENSION BAR
• 18056099649735: ACETABULAR PROBE
• 18056099649728: 13MM PIERCER PROBE - 180MM
• 18056099649711: 11MM PIERCER PROBE - 175MM
• 18056099649704: 10MM PIERCER PROBE - 175MM
• 18056099649698: 8MM PIERCER PROBE - 180MM
• 18056099649681: 6MM PIERCER PROBE - 180MM
• 18056099648660: 10MM SCRAPER PROBE - 90MM
• 18056099648653: 8MM SCRAPER PROBE - 180MM
• 18056099648646: 6MM SCRAPER PROBE - 180MM
• 18056099648639: GROOVER PROBE - 2 LOBE - 90MM
• 18056099648622: EXTRACTION PROBE FOR SLAPHAMMER
• 18053504360148: ULTRASONIC GENERATOR 115V UL
• 18053504360131: SPANNER 8/9MM
• 18053504360124: SPANNER 7MM
• 18053504360117: OSCAR 3 INSTRUMENTS SINGLE USE
• 18053504360100: OSCAR 3 INSTRUMENTS REUSABLE
• 18053504360094: OSCAR 3 GENERATOR
• 18053504360087: OSCAR 2 INSTRUMENTS SINGLE USE
• 18053504360070: OSCAR 2 INSTRUMENTS REUSABLE
• 18053504360056: EXTENSION REDUCER BAR
• 18053504360049: EXTENSION REDUCER BAR
• 18053504360032: 8MM PIERCER CURVED
• 18053504360025: OSCAR STERILIZATION TRAY
• 18053504360018: FOOTSWITCH