Identity
- Trade Name
- Nottingham One-Step FDA UDI
- Generic Name
- Endoscopic-access dilator, single-use FDA UDI
- Device Name
- URETERAL DILATORS EUDAMEDHydrogel Coated Ureteral Dilator FDA UDI
- Model / Reference
- M0062301000 EUDAMEDFDA UDI
- Description
- Hydrogel Coated Ureteral Dilator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729192053 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000603N4 EUDAMED
- FDA Product Code
- EZN FDA UDI
- EMDN Code
- U03010202 URETERAL DILATORS EUDAMED
- GMDN Term
- Endoscopic-access dilator, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5470 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Category: Ureteral introduction sheath
Ureteral Dilators by Boston Scientific — Class IIa — MDR, FDA UDI — listed in EUDAMED, 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 01915060000000000000603N4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (2)
- EUDAMED 87c71d7d-8ec4-42e1-92e4-d3a5b5c69100 61 fields · synced Jun 6, 2026
- FDA UDI 0d61e2de-a76d-4982-8cd1-9995a1adb710 34 fields · synced May 29, 2026