Identity
- Trade Name
- OBALON® Balloon System HPMC FDA UDI
- Generic Name
- Appetite-suppression gastric balloon FDA UDI
- Device Name
- OBALON® Balloon System HPMC - contains one Obalon Balloon Kit HPMC and one Obalon Accessory Kit FDA UDI
- Model / Reference
- 9600-0001 FDA UDI
- Description
- OBALON® Balloon System HPMC - contains one Obalon Balloon Kit HPMC and one Obalon Accessory Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859810006074 FDA UDI
- PMA Number
- P160001 FDA UDI
- FDA Product Code
- LTI FDA UDI
- GMDN Term
- Appetite-suppression gastric balloon FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
OBALON® Balloon System HPMC by ReShape Lifesciences Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- ReShape Lifesciences Inc.
Sources (1)
- FDA UDI 35ef00f3-0d4b-4c50-9e53-f07a4005c6b7 37 fields · synced Jun 8, 2026