Identity
- Trade Name
- UTS® Precurved Ultra Taper Sphincterotome EUDAMEDUTS FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- Sphincterotomes EUDAMEDUTS Precurved Ultra Taper Sphincterotome FDA UDI
- Model / Reference
- UTS-25M EUDAMEDG22490 FDA UDI
- Description
- UTS Precurved Ultra Taper Sphincterotome FDA UDI
Identifiers
- Catalog Number
- UTS-25M FDA UDI
- Primary DI / UDI-DI
- 00827002224902 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002WCM00000000012MF EUDAMED
- FDA Product Code
- KNS FDA UDI
- EMDN Code
- G03040201 PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Uts by Cook Incorporated — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, monopolar, single-use.
- GeniSurge — Genicon · Class II
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- Arthrex® — Arthrex, Inc. · Class II
- Short Throw — US Endoscopy · Class II
- Single Use Electrosurgical Knife KD-655 — Olympus Medical Systems Corporation · Class II
- Polyp Pak — US Endoscopy · Class II
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Cook Incorporated
Sources (2)
- FDA UDI db8748e1-2c74-40c6-908d-61484d3988ef 36 fields · synced Oct 11, 2026
- EUDAMED 7e55d966-46b8-4bf8-a220-68b8db431ac0 61 fields · synced Oct 10, 2026