AccessGUDID - DEVICE: OBALON® Balloon System (00859810006050)

GUDID

Device Identifier (DI) Information

Brand Name: OBALON® Balloon System
Version or Model: 9500-0001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Reshape Lifesciences Inc.

Primary DI Number: 00859810006050
Issuing Agency: GS1
Commercial Distribution End Date: July 12, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 022894714 *Terms of Use

Device Description: OBALON® Balloon System - contains one Obalon Balloon Kit and one Obalon Accessory Kit

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:	No
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?
17202	Appetite-suppression gastric balloon	An implantable device intended to be swallowed or endoscopically inserted into the stomach where it is inflated to reduce stomach volume and facilitate weight loss in overweight/obese patients by restricting the quantity of food consumed through an increased sense of satiety (fullness). It is designed to be inflated/filled with an inert material (e.g., saline, air, nitrogen) in situ, where it remains until it is endoscopically removed or deflates and passes through the bowels. Disposable devices dedicated to introduction/inflation may be included with the balloon.	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 [?]
P160001	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6161536-099c-42f8-a781-08cbb9e502fb
Public Version Date: January 03, 2024
Public Version Number: 7
DI Record Publish Date: December 26, 2016