ENDO-THERAPEUTICS, INC.

Address:15251 Roosevelt Blvd Ste 204,CLEARWATER,FL,33760,US

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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) (10)

Premarket Exempt

Yes No

Clear

Elliptical Basket, Large - 00816207020419 Catalog Number : BGE-1615L

Device Description : Endoscopic retrieval device, large basket

Device Class : 2

Duns Number: 825239189

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 1

Elliptical Basket, Medium - 00816207020426 Catalog Number : BGE-1615M

Device Description : Endoscopic retrieval device, medium basket

Device Class : 2

Duns Number: 825239189

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 1

Elliptical Basket, Large - 00816207020433 Catalog Number : BGE-1622L

Device Description : Endoscopic retrieval device, large elliptical basket

Device Class : 2

Duns Number: 825239189

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 1

Elliptical Basket, Medium - 00816207020440 Catalog Number : BGE-1622M

Device Description : Endoscopic retrieval device, medium basket

Device Class : 2

Duns Number: 825239189

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 1

Hexagonal Basket - Large - 00816207020457 Catalog Number : BGH-1315L

Device Description : Endoscopic retrieval device, large hexagonal basket

Device Class : 2

Duns Number: 825239189

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 1

Hexagonal Basket, Medium - 00816207020464 Catalog Number : BGH-1315M

Device Description : Endoscopic retrieval device, medium hexagonal basket

Device Class : 2

Duns Number: 825239189

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 1

Hexagonal Basket, Large - 00816207020471 Catalog Number : BGH-1615L

Device Description : Endoscopic retrieval device

Device Class : 2

Duns Number: 825239189

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 1

Hexagonal Basket, Medium - 00816207020488 Catalog Number : BGH-1615M

Device Description : Endoscopic retrieval device

Device Class : 2

Duns Number: 825239189

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 1

Hexagonal Basket, Large - 00816207020495 Catalog Number : BGH-1622L

Device Description : Endoscopic retrieval device

Device Class :

Duns Number: 825239189

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 1

Hexagonal Basket, Medium - 00816207020501 Catalog Number : BGH-1622M

Device Description : Endoscopic retrieval device

Device Class : 2

Duns Number: 825239189

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 1

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