FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OBALON®
DI: 00859810006241
·
Model: 7405-0001
·
Reshape Lifesciences Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OBALON®
- Primary DI
- 00859810006241
- Version / Model
- 7405-0001
- Company Name
- Reshape Lifesciences Inc.
- Labeler DUNS
- 022894714
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-20
- Public Version
- 3
- Public Version Date
- 2023-09-01
- Public Version Status
- Update
- Public Device Record Key
- 8ae27967-8db1-4964-b636-8918e039b99d
- Distribution End Date
- 2020-03-02
Device Description
OBALON® Recalibration Tool - component for use with the OBALON® Navigation Console
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859810006241 | GS1 |
Customer Contacts
- Phone
- 1-844-362-2566
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 104 Degrees Fahrenheit