Identity
- Trade Name
- Jade PTA FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- Percutaneous Transluminal Angioplasty Balloon Catheter FDA UDI
- Model / Reference
- L540-40080U FDA UDI
- Description
- Percutaneous Transluminal Angioplasty Balloon Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934955940736 FDA UDI
- FDA Product Code
- LIT FDA UDI
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 80 Millimeter FDA UDIOuter Diameter — 4.0 Millimeter FDA UDI
Category: Peripheral angioplasty balloon catheter, basic
Jade PTA by OrbusNeich Medical (ShenZhen) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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- RapidCross — Covidien LP · Class II
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
- OrbusNeich Medical (ShenZhen) Co., Ltd.
Sources (1)
- FDA UDI 6f3fad7f-faf6-4509-bffb-5aa328e2ec8d 36 fields · synced Jun 1, 2026