Identity
- Trade Name
- Wellead Portable Roller Irrigation Pump FDA UDI
- Generic Name
- Surgical irrigation pump FDA UDI
- Device Name
- WP-I-02 FDA UDI
- Model / Reference
- U10A020210 FDA UDI
- Description
- WP-I-02 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881167010 FDA UDI
- FDA Product Code
- FQH FDA UDI
- GMDN Term
- Surgical irrigation pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Surgical irrigation pump
Wellead Portable Roller Irrigation Pump by Well Lead Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation pump.
- CS-10-30-315 OpClear Disposable — Cipher Surgical, Ltd. · Class II
- CS-05-30-300 OpClear Disposable — Cipher Surgical, Ltd. · Class II
- CS-10-00-330 OpClear Disposable — Cipher Surgical, Ltd. · Class II
- BEAMER AVEO IRRIGATION PUMP HEAD REPLACEMENT PART — Chongqing Jinshan Science & Technology (Group) Co., Ltd · Class II
- Torrent — US Endoscopy · Class II
- CS-CU15-03 OpClear Control Unit — Cipher Surgical, Ltd. · Class II
- CS-05-30-290 OpClear Disposable — Cipher Surgical, Ltd. · Class II
- Sutter — Sutter Medizintechnik GmbH · 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
- Well Lead Medical Co., Ltd
Sources (1)
- FDA UDI 686d24ea-1813-4aeb-ba10-f1bc0de4d66c 33 fields · synced Jun 1, 2026