AccessGUDID - DEVICE: OBALON® (00859810006241)

GUDID

Device Identifier (DI) Information

Brand Name: OBALON®
Version or Model: 7405-0001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Reshape Lifesciences Inc.

Primary DI Number: 00859810006241
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® Recalibration Tool - component for use with the OBALON® Navigation Console

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8ae27967-8db1-4964-b636-8918e039b99d
Public Version Date: September 01, 2023
Public Version Number: 3
DI Record Publish Date: February 20, 2019