Identity
- Trade Name
- Ureteral Access Sheath FDA UDI
- Generic Name
- Ureteral introduction sheath FDA UDI
- Device Name
- 10Fr×13cm FDA UDI
- Model / Reference
- U03B011013 FDA UDI
- Description
- 10Fr×13cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881134234 FDA UDI
- 510(k) Number
- K151084 FDA UDI
- FDA Product Code
- FED FDA UDI
- GMDN Term
- Ureteral introduction sheath FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Category: Ureteral introduction sheath
Ureteral Access Sheath by Well Lead Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral introduction sheath.
- Manawa Access Sheath — ENVASTE LTD · Class IIa
- Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
- Disposable Ureteral Guide Sheath — Dongguan ZSR Biomedical Technology Company Limited · Class IIa
- Disposable access sheath — Hangzhou Hawk Medical Technology Co., Ltd · Class IIa
- Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd · Class II
Cleared under the same submission
K151084 also covers:
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical 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 II | Pending data |
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Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd
Sources (1)
- FDA UDI 4e07e129-d2ca-4238-aeac-1f81a21afc90 34 fields · synced Jun 6, 2026