Identity
- Trade Name
- Percutaneous Nephrostomy Dilator FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- 14Fr x 22cm FDA UDI
- Model / Reference
- U02E011422 FDA UDI
- Description
- 14Fr x 22cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881156779 FDA UDI
- FDA Product Code
- GCC FDA UDI
- GMDN Term
- Endoscopic-access dilator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic-access dilator, reusable
Percutaneous Nephrostomy Dilator by Well Lead Medical Co., Ltd — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd
Sources (1)
- FDA UDI 4a9d19be-eb2d-4fc3-8c39-6f01fa5828ff 33 fields · synced Jun 8, 2026