AccessGUDID - DEVICE: ReShape Lap-Band® 2.0 FLEX, Large (00850007764517)

GUDID

Device Identifier (DI) Information

Brand Name: ReShape Lap-Band® 2.0 FLEX, Large
Version or Model: D-3365
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D-3365
Company Name: ReShape Lifesciences Inc.

Primary DI Number: 00850007764517
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022894714 *Terms of Use

Device Description: ReShape Lap-Band® 2.0 FLEX, Large

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LTI	Implant, Intragastric For Morbid Obesity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000008	048

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Large

Device Record Status

Public Device Record Key: 275bb08d-b969-4958-91ff-316174f2c56f
Public Version Date: July 18, 2025
Public Version Number: 2
DI Record Publish Date: January 22, 2024