ENDOCHOICE, INC.

ENDOCHOICE, INC.

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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

Endoscopic Grasping/Cutting Instrument, Non-Powered (OCZ) (4) Ligator, Esophageal (MND) (4) Endoscopic Irrigation/Suction System (OCX) (2)

Premarket Exempt

No

Clear

Auto-Band® - 00816849010007 Catalog Number :

Device Description : Ligator Assembly & Band Barrel w/7 non-Latex Bands

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : MND

Prescription Use : Yes

Device Count : 1

Auto-Band® - 00816849010014 Catalog Number :

Device Description : Ligator Assembly & Band Barrel w/7 Latex Bands

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : MND

Prescription Use : Yes

Device Count : 1

Auto-Band® - 00816849010021 Catalog Number :

Device Description : Ligator Assembly & Band Barrel w/7 Latex Bands

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : MND

Prescription Use : Yes

Device Count : 1

Auto-Band® - 00816849010038 Catalog Number :

Device Description : Ligator Assembly & Band Barrel w/7 non-Latex Bands

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : MND

Prescription Use : Yes

Device Count : 1

Seal® - 00816849010113 Catalog Number :

Device Description : Biopsy Valve

Device Class :

Duns Number: 014154279

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 100

Seal® - 00816849010120 Catalog Number :

Device Description : Biopsy Valve

Device Class :

Duns Number: 014154279

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 100

Rescue® - 00816849017303 Catalog Number :

Device Description : Alligator Grasping Forceps

Device Class :

Duns Number: 014154279

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 5

Rescue® - 00816849017310 Catalog Number :

Device Description : Alligator Grasping Forceps , Long

Device Class :

Duns Number: 014154279

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 5

Rescue® - 00816849017327 Catalog Number :

Device Description : Rat tooth/Alligator Grasping Forceps

Device Class :

Duns Number: 014154279

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 5

Rescue® - 00816849017334 Catalog Number :

Device Description : Rat tooth Grasping Forceps

Device Class :

Duns Number: 014154279

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 5

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