RESHAPE MEDICAL, INC.

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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

Implant, Intragastric For Morbid Obesity (LTI) (4)

Premarket Exempt

Clear

ReShape™ Integrated Dual Balloon System - B001RSM1011 Catalog Number : RSM101

Device Description : IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY

Device Class : 3

Duns Number: 877283486

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

ReShape® Integrated Dual Balloon System - B001RSM1101 Catalog Number : RSM110

Device Description : IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY

Device Class : 3

Duns Number: 877283486

Premarket Exempt : No

Product Code : LTI

Prescription Use : No

Device Count : 1

ReShape™ Removal Catheter - B001RSM2101 Catalog Number : RSM210

Device Description : ReShape™ Removal Catheter - component to remove the ReShape™ Integrated Dual Balloon

Device Class : 3

Duns Number: 877283486

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

ReShape™ Valve Sealant - B001RSM9001 Catalog Number : RSM900

Device Description : ReShape™ Valve Sealant - component for use with the ReShape™ Integrated Dual Balloon

Device Class : 3

Duns Number: 877283486

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

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