Identity
- Trade Name
- Evolution FDA UDI
- Generic Name
- Bare-metal duodenal stent FDA UDI
- Device Name
- EVOLUTION DUODENAL, STENT SYSTEM - UNCOVERED FDA UDI
- Model / Reference
- G48027 FDA UDI
- Description
- EVOLUTION DUODENAL, STENT SYSTEM - UNCOVERED FDA UDI
Identifiers
- Catalog Number
- EVO-22-27-12-D FDA UDI
- Primary DI / UDI-DI
- 10827002480275 FDA UDI
- FDA Product Code
- MUM FDA UDI
- GMDN Term
- Bare-metal duodenal stent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3610 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
MR Conditional FDA UDI
Category: Bare-metal duodenal stent
Evolution by Cook Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bare-metal duodenal stent.
- WALLSTENT™ Enteral Endoprosthesis — Boston Scientific · Class II
- Niti-S Duodenal Comfort Stent — Taewoong Medical · Class II
- WallFlex™ Duodenal — Boston Scientific · Class II
- HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) — M.I.Tech Co., Ltd. · Class II
- HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) — M.I.Tech Co., Ltd. · Class II
- Niti-S Duodenal Comfort Stent — Taewoong Medical · Class II
- HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) — M.I.Tech Co., Ltd. · Class II
- HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) — M.I.Tech Co., Ltd. · 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
- Cook Ireland, Ltd.
Sources (1)
- FDA UDI f5a2c1eb-88b9-4d0d-95ed-a32bd909c44c 36 fields · synced May 31, 2026