AccessGUDID - DEVICE: OBALON® (00859810006180)

GUDID

Device Identifier (DI) Information

Brand Name: OBALON®
Version or Model: 7402-0001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Reshape Lifesciences Inc.

Primary DI Number: 00859810006180
Issuing Agency: GS1
Commercial Distribution End Date: March 02, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 022894714 *Terms of Use

Device Description: OBALON® Navigation Console - component to visualize the OBALON® Balloon

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
44924	Gastrointestinal catheter/endoscope tracking system	A multicomponent assembly of mains electricity (AC-powered) devices designed for real-time visualization/navigation of a catheter and/or endoscope during insertion in the gastrointestinal tract, by detecting its position/movement within an electromagnetic (EM) field and displaying three-dimensional (3-D) virtual images on a monitoring screen. The system primarily consists of a main control unit with monitor and an external EM field generator or sensor, and may also require/include an external reference sensor; additional accessories (e.g., remote control, stand/trolley) may also be included.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Special Storage Condition, Specify: Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between 14 and 104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1e267c52-01d6-48a9-8ce5-ed681bb7510a
Public Version Date: September 01, 2023
Public Version Number: 3
DI Record Publish Date: February 20, 2019