THE O R COMPANY PTY LTD

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

Instrument, Ligature Passing And Knot Tying (HCF) (6) Instrument, Manual, Surgical, General Use (MDM) (3) Laparoscopic Accessories, Gynecologic (NWV) (1)

Premarket Exempt

No Yes

Clear

Suture PassOR Pro - 09349967000366 Catalog Number :

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : HCF

Prescription Use : Yes

Device Count : 1

QuivOR - 09349967000458 Catalog Number :

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

QuivOR - 09349967000472 Catalog Number :

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

QuivOR - 09349967000496 Catalog Number :

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Suture PassOR - 09349967000519 Catalog Number :

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : HCF

Prescription Use : Yes

Device Count : 1

Suture PassOR - 09349967000540 Catalog Number :

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : HCF

Prescription Use : Yes

Device Count : 1

Suture PassOR Pro - 09349967000571 Catalog Number :

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : HCF

Prescription Use : Yes

Device Count : 1

Suture PassOR Pro - 09349967000632 Catalog Number :

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : HCF

Prescription Use : Yes

Device Count : 1

Scope CleanOR - 09349967000656 Catalog Number : SC-01

Device Description : Scope and Trocar Cleaning Device

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : NWV

Prescription Use : Yes

Device Count : 1

Port ClosOR Pro - 09349967000694 Catalog Number :

Device Class : 1

Duns Number: 744346235

Premarket Exempt : Yes

Product Code : HCF

Prescription Use : Yes

Device Count : 1

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