THE O R COMPANY PTY LTD

Address:4/47 Wangara Road,Cheltenham Victoria,AU

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cannula, Manipulator/Injector, Uterine (LKF) (6) Instrument, Manual, Surgical, General Use (MDM) (3) Accessories, Cleaning Brushes, For Endoscope (MNL) (1)

Premarket Exempt

No Yes

Clear

HolstOR Pro - 09349967002872 Catalog Number : HPRO-250

Device Description : Surgical Instrument Holder

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

HolstOR Pro - 09349967002896 Catalog Number : HPRO-330

Device Description : Surgical Instrument Holder

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

HolstOR Pro - 09349967002919 Catalog Number : HPRO-410

Device Description : Surgical Instrument Holder

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Scope CleanOR - 09349967002933 Catalog Number :

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

Uterine ElevatOR Pro - 09349967002964 Catalog Number :

Device Class : 2

Duns Number: 744346235

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

Uterine ElevatOR Pro - 09349967002995 Catalog Number :

Device Class : 2

Duns Number: 744346235

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

Uterine ElevatOR Pro - 09349967003022 Catalog Number :

Device Class : 2

Duns Number: 744346235

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

Uterine ElevatOR Pro - 09349967003053 Catalog Number :

Device Class : 2

Duns Number: 744346235

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

Uterine PositionOR - 09349967003084 Catalog Number :

Device Class :

Duns Number: 744346235

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

ManipulatOR - 09349967003114 Catalog Number :

Device Class :

Duns Number: 744346235

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

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