ETHICON ENDO-SURGERY, INC.

Address:4545 CREEK RD.,Cincinnati,OH,45242,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

Computer-assisted personalized sedation system (PDR) (6) Dilator, esophageal (KNQ) (3)

Premarket Exempt

Clear

SEDASYS - 20705036003615 Catalog Number : SEDBPSM

Device Description : NIBP Cuff - Adult Small

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

SEDASYS - 20705036003776 Catalog Number : SEDE3AMI

Device Description : ECG Leads AAMI Color Std

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

SEDASYS - 20705036003783 Catalog Number : SEDECAMI

Device Description : ECG Cable AAMI Color Std

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

SEDASYS - 20705036003806 Catalog Number : SEDOXEC

Device Description : Pulse Oximeter Sensor - Extension Cable

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

SEDASYS - 20705036003813 Catalog Number : SEDOXFP

Device Description : Pulse Oximeter Sensor - Finger Probe

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

N/A - 20705036003899 Catalog Number : OD016

Device Description : Optical Dilator

Device Class : 2

Duns Number: 123407392

Premarket Exempt : No

Product Code : KNQ

Prescription Use : Yes

Device Count : 1

N/A - 20705036003905 Catalog Number : OD018

Device Description : Optical Dilator

Device Class : 2

Duns Number: 123407392

Premarket Exempt : No

Product Code : KNQ

Prescription Use : Yes

Device Count : 1

N/A - 20705036003912 Catalog Number : OD020

Device Description : Optical Dilator

Device Class : 2

Duns Number: 123407392

Premarket Exempt : No

Product Code : KNQ

Prescription Use : Yes

Device Count : 1

SEDASYS - 20705036010224 Catalog Number : SED15LCD

Device Description : SEDASYS DISPLAY MONITOR

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

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