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Ureteral Access Sheath
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref U03B011435Model Ureteral Access Sheath
Identity
- Trade Name
- Wellead Ureteral Access Sheath EUDAMEDUreteral Access Sheath FDA UDI
- Generic Name
- Ureteral introduction sheath FDA UDI
- Device Name
- Ureteral Access Sheath EUDAMED14Fr×35cm FDA UDI
- Model / Reference
- U03B011435 EUDAMEDFDA UDIUreteral Access Sheath EUDAMED
- Description
- 14Fr×35cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944932787667 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449327FU03B01LP EUDAMED
- 510(k) Number
- K151084 FDA UDI
- FDA Product Code
- FED FDA UDI
- EMDN Code
- U03010202 URETERAL DILATORS EUDAMED
- GMDN Term
- Ureteral introduction sheath FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
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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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI d5d63b41-6742-4518-ba02-b62d48302be4 34 fields · synced Jul 11, 2026
- EUDAMED 5c87603c-9a29-4579-b29e-5fc00b751627 61 fields · synced Jul 9, 2026