Identity
- Trade Name
- BALLOON SHEATH FDA UDI
- Generic Name
- Ultrasound endoscope balloon, Hevea-latex FDA UDI
- Device Name
- This model includes one of connector section and five of insertion sections. The connector section is reusable and requires autoclave sterilization prior to use. The insertion section is single-use and packaged as sterile. Please refer to the instruction manual for details. FDA UDI
- Model / Reference
- MH-246R FDA UDI
- Description
- This model includes one of connector section and five of insertion sections. The connector section is reusable and requires autoclave sterilization prior to use. The insertion section is single-use and packaged as sterile. Please refer to the instruction manual for details. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170365126 FDA UDI
- 510(k) Number
- K961048 FDA UDI
- FDA Product Code
- FED FDA UDIODG FDA UDI
- GMDN Term
- Ultrasound endoscope balloon, Hevea-latex FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultrasound endoscope balloon, Hevea-latex
Balloon Sheath by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- BALLOON SHEATH — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI e145a256-d84a-4e56-a76a-cb1810ec62f9 35 fields · synced May 30, 2026