ReShape Lap-Band® 2.0 FLEX, Large

Basic Information

• Brand Name: ReShape Lap-Band® 2.0 FLEX, Large
• Primary DI: 00850007764517
• Version / Model: D-3365
• Catalog Number: D-3365
• Company Name: Reshape Lifesciences Inc.
• Labeler DUNS: 022894714
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-22
• Public Version: 1
• Public Version Date: 2024-01-30
• Public Version Status: New
• Public Device Record Key: 275bb08d-b969-4958-91ff-316174f2c56f

Device Description

ReShape Lap-Band® 2.0 FLEX, Large

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LTI	Implant, Intragastric For Morbid Obesity	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
17649	Gastric band	An implantable device in the form of a small belt or strip intended to be surgically (open surgery or laparoscopically) placed around the proximal part of the stomach to create a small pouch with a narrowed outlet (stoma) that divides the stomach into two portions. Commonly known as a lap-band, it is used for weight loss in overweight/obese patients by attempting to restrict the quantity of food consumed by increasing the sense of satiety (fullness). The device typically has an inflatable band used to control the amount of constriction on the stomach; this is adjusted by percutaneous injection of, e.g., saline, into a subcutaneous access port connected by a tube to the device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850007764517	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P000008	048

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Large

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged and consult instructions for use