FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OBALON®
DI: 00859810006142
·
Model: 6200-0001
·
Reshape Lifesciences Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OBALON®
- Primary DI
- 00859810006142
- Version / Model
- 6200-0001
- 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
- 93c43471-06ce-4542-9c36-6f451c3299f6
- Distribution End Date
- 2020-03-02
Device Description
OBALON® Accessory Kit - Ejectors - component for use with the OBALON® Balloon
Device Characteristics
- Single Use
- Yes
- 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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| 63405 | Appetite-suppression gastric balloon deployment device/set | A non-sterile, noninvasive device/collection of devices intended to be used in conjunction with an inflation regulator (not included) to support deployment of a gastric balloon in the stomach. It may include extension tubing, designed to connect the inflation regulator to the catheter, valves/connectors, or a balloon ejection syringe intended to inject fluid with enough pressure to disconnect the catheter from the balloon once fully inflated in situ; it includes at least one devices dedicated to appetite-suppression gastric balloon deployment. Neither the catheter nor balloon are included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859810006142 | GS1 |
Customer Contacts
- Phone
- 1-844-362-2566
- [email protected]