Reshape Lifesciences Inc.

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

neuromodulator for obesity (PIM) (4) Implant, Intragastric For Morbid Obesity (LTI) (2)

Premarket Exempt

Clear

Model 2403-60 Maestro Patient Transmit Coil - 00857334004323 Catalog Number : 2403-60

Device Description : The Model 2403-60 Transmit Coil is a non-sterile external component for use by t The Model 2403-60 Transmit Coil is a non-sterile external component for use by the patient. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication.

Device Class : 3

Duns Number: 144998551

Premarket Exempt : No

Product Code : PIM

Prescription Use : Yes

Device Count : 1

Model 2404 Maestro Patient Kit - 00857334004347 Catalog Number : 2404

Device Description : The Model 2404 Patient Kit consists of a Model 2402 Mobile Charger, a Model 2403 The Model 2404 Patient Kit consists of a Model 2402 Mobile Charger, a Model 2403-60 Patient Transmit Coil, a Model 1620 AC Recharger, and a Model 1660 Patient Transmit Coil Belt that are packaged together.

Device Class : 3

Duns Number: 144998551

Premarket Exempt : No

Product Code : PIM

Prescription Use : Yes

Device Count : 1

Model 2502 Maestro Clinician Programmer - 00857334004354 Catalog Number : 2502

Device Description : The Model 2502 Clinician Programmer (CP) is a non-sterile external component tha The Model 2502 Clinician Programmer (CP) is a non-sterile external component that consists of a commercially available laptop computer configured with customized software. The CP connects to the Mobile Charger with a custom Programmer Cable. The CP enables the clinician to enter and modify therapy parameters and therapy schedule in the Rechargeable Neuroregulator. The graphical user interface of the CP allows the clinician to monitor system performance and patient compliance. The CP also provides access to the Instructions for Use manuals.

Device Class : 3

Duns Number: 144998551

Premarket Exempt : No

Product Code : PIM

Prescription Use : Yes

Device Count : 1

Model 2504 Maestro Clinician Programmer Kit - 00857334004361 Catalog Number : 2504

Device Description : The Model 2504 Clinician Programmer Kit consists of a Model 2502 Clinician Progr The Model 2504 Clinician Programmer Kit consists of a Model 2502 Clinician Programmer, a Model 2402 Mobile Charger, a Model 2403-300 Clinician Transmit Coil, a Model 1620 AC Recharger, and a Model 1600 Programmer Cable that are packaged together.

Device Class : 3

Duns Number: 144998551

Premarket Exempt : No

Product Code : PIM

Prescription Use : Yes

Device Count : 1

LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.) - 10850007764323 Catalog Number : B-20302-10

Device Description : LAP-BAND Access Port Needle 2 inch Pouch

Device Class :

Duns Number: 144998551

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 10

LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.) - 10850007764330 Catalog Number : B-20301-10

Device Description : LAP-BAND Access Port Needle 3.5 inch Pouch

Device Class :

Duns Number: 144998551

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 10

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