Obtech Medical Sàrl

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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

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY (LTI) (2) TUBES, GASTROINTESTINAL (AND ACCESSORIES) (KNT) (2) DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY (GDI) (1)

Premarket Exempt

No Yes

Clear

N/A - 20705036003967 Catalog Number : RGBRS1

Device Description : Gastric Band Dissector

Device Class : 1

Duns Number: 486911852

Premarket Exempt : Yes

Product Code : GDI

Prescription Use : Yes

Device Count : 1

N/A - 20705036003974 Catalog Number : RGCT180

Device Description : Gastric Calibration Tube

Device Class : 2

Duns Number: 486911852

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

N/A - 20705036003981 Catalog Number : RGCT360

Device Description : Gastric Calibration Tube

Device Class : 2

Duns Number: 486911852

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

NA - 20705036004001 Catalog Number : RLZB32

Device Description : Curved Adjustable Gastric Band with Sutureless Port and Applier

Device Class : 3

Duns Number: 486911852

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

NA - 20705036004018 Catalog Number : RLZPT2

Device Description : Gastric Band Sutureless Port and Applier

Device Class : 3

Duns Number: 486911852

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

NA - 20705036011665 Catalog Number : RLZB22T

Device Description : GASTRIC BAND KIT

Device Class :

Duns Number: 486911852

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

NA - 20705036011672 Catalog Number : RLZB32D1

Device Description : GASTRIC BAND KIT

Device Class :

Duns Number: 486911852

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

NA - 20705036011689 Catalog Number : RLZB32DG1

Device Description : GASTRIC BAND KIT

Device Class :

Duns Number: 486911852

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

NA - 20705036011696 Catalog Number : RLZB32DGT

Device Description : GASTRIC BAND KIT

Device Class :

Duns Number: 486911852

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

NA - 20705036011702 Catalog Number : RLZB32DT

Device Description : GASTRIC BAND KIT

Device Class :

Duns Number: 486911852

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

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