Identity
- Trade Name
- Scoreflex NC Scoring PTCA Catheter FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, cutting/scoring FDA UDI
- Model / Reference
- 622-104-1U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934955936319 FDA UDI
- PMA Number
- P200041 FDA UDI
- FDA Product Code
- NWX FDA UDI
- GMDN Term
- Coronary angioplasty balloon catheter, cutting/scoring FDA UDI
Classification
- Device Class
- Class III 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
No
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
Category: Coronary angioplasty balloon catheter, cutting/scoring
Scoreflex NC Scoring PTCA Catheter by OrbusNeich Medical (ShenZhen) Co., Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- Kulani™ NC — Meril Life Sciences Pvt. Ltd. · Class III
- Invader PTCA — Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. · Class III
- Wolverine Coronary Cutting Balloon — Boston Scientific · Class III
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- POT — BrosMed Medical Co., Ltd. · Class III
Cleared under the same submission
P200041 also covers:
- Scoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.
- Scoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.
- Scoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.
- Scoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.
- Scoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.
- Scoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.
- Scoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.
- Scoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.
- Scoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.
- Scoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.
- Scoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.
- Scoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.
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
- OrbusNeich Medical (ShenZhen) Co., Ltd.
Sources (1)
- FDA UDI f3d80583-4a92-44e3-b709-dd02b790b7ee 33 fields · synced May 31, 2026