Reshape Lifesciences Inc.

Address:1001 Calle Amanecer,San Clemente,CA,92673,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

Implant, Intragastric For Morbid Obesity (LTI) (5) Tubes, Gastrointestinal (And Accessories) (KNT) (5)

Premarket Exempt

Clear

RapidPort® EZ Access Port Kit - 10cc - 00850007764043 Catalog Number : C-2304

Device Description : RapidPort EZ Access Port Kit (0-10cc)

Device Class : 3

Duns Number: 144998551

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

RapidPort® EZ Access Port Kit - 14cc - 00850007764067 Catalog Number : C-2306

Device Description : RapidPort EZ Access Port Kit (0-14cc)

Device Class : 3

Duns Number: 144998551

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

LAP-BAND® System Calibration Tube - 00850007764173 Catalog Number : B-2017

Device Description : LAP-BAND System Calibration Tube

Device Class : 3

Duns Number: 144998551

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

Gastric Balloon Suction Catheter - 00850007764203 Catalog Number : B-2020

Device Description : Bio Gastric Balloon Suction Catheter

Device Class : 2

Duns Number: 144998551

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

GIBI HD - 00850007764210 Catalog Number : B-2032

Device Description : Gastrointestinal Boundary Identification and Sizing Tube 32 French

Device Class : 2

Duns Number: 144998551

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

GIBI HD - 00850007764227 Catalog Number : B-2036

Device Description : Gastrointestinal Boundary Identification and Sizing Tube 36 French

Device Class : 2

Duns Number: 144998551

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

GIBI HD - 00850007764234 Catalog Number : B-2040

Device Description : Gastrointestinal Boundary Identification and Sizing Tube 40 French

Device Class : 2

Duns Number: 144998551

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

LAP-BAND AP® System Standard with RapidPort® EZ - 00850007764609 Catalog Number : C-2360

Device Description : The LAP-BAND AP Adjustable Gastric Banding System Standard with RapidPort EZ

Device Class : 3

Duns Number: 144998551

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

LAP-BAND AP® System Large with RapidPort® EZ - 00850007764654 Catalog Number : C-2365

Device Description : The LAP-BAND AP Adjustable Gastric Banding System Large with RapidPort EZ

Device Class : 3

Duns Number: 144998551

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

RapidPort® EZ Port Applier - 00850007764906 Catalog Number : C-20390

Device Description : RapidPort EZ Applier Tool

Device Class : 3

Duns Number: 144998551

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

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