Identity
- Trade Name
- INOUE BALLOON A FDA UDI
- Generic Name
- Cardiac valvuloplasty catheter FDA UDI
- Model / Reference
- PTAV-24R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14960685201242 FDA UDI
- FDA Product Code
- OZT FDA UDI
- GMDN Term
- Cardiac valvuloplasty catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1255 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
Yes
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
Dimensions & Sizes
- Size
- Length — 105 Centimeter FDA UDICatheter Gauge — 10 French FDA UDI
Category: Cardiac valvuloplasty catheter
Inoue Balloon A by Toray Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Toray Industries, Inc.
Sources (1)
- FDA UDI aae2ef76-063f-446a-801a-eb68129a4aa1 35 fields · synced May 30, 2026