US Endoscopy

Address:583 N SMITH AVE STE B,Corona,CA,92880,US

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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

ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE (MNL) (4) Electrosurgical, cutting & coagulation & accessories (GEI) (3) INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE (FCX) (2) TABLE AND ATTACHMENTS, OPERATING-ROOM (BWN) (1)

Premarket Exempt

No Yes

Clear

Revital-Ox - 00724995002039 Catalog Number : 2D75QV

Device Description : The Revital-Ox Single-Ended Channel Brush support effective cleaning inside lume The Revital-Ox Single-Ended Channel Brush support effective cleaning inside lumened instruments with the comfort of a flexible, stainless steel handle delivering control while gentle, nylon bristles dislodge bioburden from hard-to-reach interior channels.

Device Class : 1

Duns Number: 627879687

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

Revital-Ox - 00724995002046 Catalog Number : 2D76QH

Device Description : Revital-Ox Dual Ended Pull Through Channel Brush support effective cleaning insi Revital-Ox Dual Ended Pull Through Channel Brush support effective cleaning inside lumened instruments with the comfort of a flexible stainless steel handle delivering control while gentle nylon bristles dislodge bioburden from hard to reach interior channels.

Device Class : 1

Duns Number: 627879687

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

Revital-Ox - 00724995002053 Catalog Number : 2D77QH

Device Description : Revital-Ox All-In-One Channel and Valve Control Brush support effective cleaning Revital-Ox All-In-One Channel and Valve Control Brush support effective cleaning inside lumened instruments with the control of a flexible stainless steel handle delivering control while gentle nylon bristles dislodge bioburden from hard to reach interior channels.

Device Class : 1

Duns Number: 627879687

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

Revital-Ox - 00724995002060 Catalog Number : 2D78QV

Device Description : Revital-Ox Valve Control Brush support effective cleaning inside lumened instrum Revital-Ox Valve Control Brush support effective cleaning inside lumened instruments with the comfort of a flexible, stainless steel handle delivering control while gentle, nylon bristles dislodge bioburden from hard-to-reach interior channels.

Device Class : 1

Duns Number: 627879687

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

NA - 00724995180256 Catalog Number : G1110001

Device Description : The gi4000 Electrosurgical Unit is designed specifically for flexible endoscopy The gi4000 Electrosurgical Unit is designed specifically for flexible endoscopy and has Argon, Monopolar, Bipolar and Lavage functions all built into the one easy-to-use, compact unit.

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

NA - 00724995180263 Catalog Number : G1200000

Device Description : The gi4000 Electrosurgical Unit -Loaner is designed specifically for flexible en The gi4000 Electrosurgical Unit -Loaner is designed specifically for flexible endoscopy and has Argon, Monopolar, Bipolar and Lavage functions all built into the one easy-to-use, compact unit.

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

ArConnect - 00724995180287 Catalog Number : G1120020

Device Description : The ArConnect argon probe connector allows the delivery of monopolar high freque The ArConnect argon probe connector allows the delivery of monopolar high frequency electrosurgical energy and argon gas to a single use argon coagulation probe (not included) and is for the exclusive use with the gi4000 Electrosurgical Unit.

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Mio - 00724995180331 Catalog Number : 00711750

Device Description : The Mio medical device organizer provides three pouches and helps maintain stora The Mio medical device organizer provides three pouches and helps maintain storage and organization of the various devices used throughout endoscopic procedure(s).

Device Class : 1

Duns Number: 627879687

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : Yes

Device Count : 1

NA - 00724995180355 Catalog Number : 390513

Device Description : For use with US Endoscopy CO2 Insufflators in conjunction with medical grade CO2 For use with US Endoscopy CO2 Insufflators in conjunction with medical grade CO2 cylinders with DIN 477 standard connectors.

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : FCX

Prescription Use : Yes

Device Count : 1

CO2MPACT - 00724995180362 Catalog Number : 710300

Device Description : The CO2MPACT Endoscopic Insufflator System is designed to use CO2 as a distentio The CO2MPACT Endoscopic Insufflator System is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : FCX

Prescription Use : Yes

Device Count : 1

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