STERIS

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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

TABLE, OPERATING-ROOM, ELECTRICAL (GDC) (3) FORCEPS, BIOPSY, ELECTRIC (KGE) (1) INSTRUMENT, MANUAL, SURGICAL, GENERAL USE (MDM) (1) Operating Room Accessories Table Tray (FWZ) (1) TABLE AND ATTACHMENTS, OPERATING-ROOM (BWN) (1)

Premarket Exempt

No Yes

Clear

NA - 00724995177799 Catalog Number : BF788

Device Description : Fast rotary self-locking clamp

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

NA - 00724995216825 Catalog Number : ST0161000

Device Description : The Cmax X-Ray Imaging Table has a carbon fiber floating tabletop and can be ope The Cmax X-Ray Imaging Table has a carbon fiber floating tabletop and can be operated in standalone mode or powered patient transfer.

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : GDC

Prescription Use : No

Device Count : 1

NA - 00724995216856 Catalog Number : BF787

Device Description : Removable rail for CMAX XRAY is used with the Cmax X-Ray Imaging Table.

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

NA - 00724995218355 Catalog Number : BF714

Device Description : CMAX Xray Joystick is used with the CMAX X-Ray Imaging Table.

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : GDC

Prescription Use : No

Device Count : 1

NA - 00724995218362 Catalog Number : BF713

Device Description : The CMAX X-Ray Remote Control is used with the CMAX X-Ray Imaging Table.

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : GDC

Prescription Use : No

Device Count : 1

NA - 00816765011461 Catalog Number : 00711211

Device Description : The Biopsy Forceps Hot is a disposable biopsy forceps used to obtain mucosal tis The Biopsy Forceps Hot is a disposable biopsy forceps used to obtain mucosal tissue samples during endoscopic procedures.

Device Class : 2

Duns Number: 569317142

Premarket Exempt : No

Product Code : KGE

Prescription Use : Yes

Device Count : 1

HexaLux - 10724995172500 Catalog Number : EXLHAN3

Device Description : The HexaLux Sterilizable Light Handle is used with the HexaLux Exam Light.

Device Class : 1

Duns Number: 569317142

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 3

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