OSCAR 3 OHRE2000

GUDID 18053504360049

EXTENSION REDUCER BAR

ORTHOFIX SRL

Hard-tissue ultrasonic surgical system Hard-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system
Primary Device ID18053504360049
NIH Device Record Keyfcbf10e1-9032-49a6-a86e-4f4b93121bdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSCAR 3
Version Model Number1
Catalog NumberOHRE2000
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it

Device Identifiers

Device Issuing AgencyDevice ID
GS118053504360049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZVSystem, Cement Removal Extraction

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18053504360049]

Moist Heat or Steam Sterilization

[18053504360049]

Moist Heat or Steam Sterilization

[18053504360049]

Moist Heat or Steam Sterilization

[18053504360049]

Moist Heat or Steam Sterilization

[18053504360049]

Moist Heat or Steam Sterilization

[18053504360049]

Moist Heat or Steam Sterilization

[18053504360049]

Moist Heat or Steam Sterilization

[18053504360049]

Moist Heat or Steam Sterilization

[18053504360049]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-24
Device Publish Date2017-09-18

On-Brand Devices [OSCAR 3]

18056099649995BONECUTTER OSTEOTOME HANDSET
18056099649988CEMENT REMOVAL HANDSET
18056099649971ULTRASONIC GENERATOR 230V CE
18056099649964LONG EXTENSION REDUCER BAR FOR SINGLE USE PROBES
18056099649957SHORT EXTENSION REDUCER BAR FOR SINGLE USE PROBES
18056099649940SINGLE USE LONG EXTENSION REDUCER BAR – STERILE
18056099649933SINGLE USE SHORT EXTENSION REDUCER BAR – STERILE
18056099649926SINGLE USE 2 LOBED GROOVER PROBE – STERILE
18056099649919SINGLE USE FLAT PIERCER PROBE – STERILE
18056099649902REDUCER BAR FOR OHP218FSU
18056099649896SINGLE USE 8MM HOE PROBE – STERILE
18056099649889SINGLE USE 6MM HOE PROBE - 180MM – STERILE
18056099649872SINGLE USE 6MM SERRATED CURVED OSTEOTOME – STERILE
18056099649865SINGLE USE 6MM FLAT OSTEOTOME – STERILE
18056099649858SINGLE USE 6MM SERRATED OSTEOTOME – STERILE
18056099649841SINGLE USE ACETABULAR PROBE – STERILE
18056099649834SINGLE USE EXTRACTION PROBE FOR SLAPHAMMER – STERILE
18056099649827SLAPHAMMER (CONSUMABLE)
18056099649810SINGLE USE 6MM SCRAPER PROBE - SLIM - 180MM – STERILE
18056099649803SINGLE USE 6MM PIERCER PROBE - SLIM - 180MM – STERILE
18056099649797SINGLE USE 10MM SCRAPER PROBE - 80MM – STERILE
18056099649780SINGLE USE 8MM SCRAPER PROBE - 80MM – STERILE
18056099649773SINGLE USE 10MM PIERCER PROBE – STERILE
18056099649766SINGLE USE 8MM PIERCER PROBE – STERILE
18056099649759BONECUTTER - EXTENSION BAR
18056099649742EXTENSION BAR
18056099649735ACETABULAR PROBE
1805609964972813MM PIERCER PROBE - 180MM
1805609964971111MM PIERCER PROBE - 175MM
1805609964970410MM PIERCER PROBE - 175MM
180560996496988MM PIERCER PROBE - 180MM
180560996496816MM PIERCER PROBE - 180MM
1805609964866010MM SCRAPER PROBE - 90MM
180560996486538MM SCRAPER PROBE - 180MM
180560996486466MM SCRAPER PROBE - 180MM
18056099648639GROOVER PROBE - 2 LOBE - 90MM
18056099648622EXTRACTION PROBE FOR SLAPHAMMER
18053504360148ULTRASONIC GENERATOR 115V UL
18053504360131SPANNER 8/9MM
18053504360124SPANNER 7MM
18053504360117OSCAR 3 INSTRUMENTS SINGLE USE
18053504360100OSCAR 3 INSTRUMENTS REUSABLE
18053504360094OSCAR 3 GENERATOR
18053504360087OSCAR 2 INSTRUMENTS SINGLE USE
18053504360070OSCAR 2 INSTRUMENTS REUSABLE
18053504360056EXTENSION REDUCER BAR
18053504360049EXTENSION REDUCER BAR
180535043600328MM PIERCER CURVED
18053504360025OSCAR STERILIZATION TRAY
18053504360018FOOTSWITCH
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