Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- Cook, Coagulating Perforated Resector 26FR For Use With ACMI USA/Elite Resectoscope(26FR) FDA UDI
- Model / Reference
- G46247 FDA UDI
- Description
- Cook, Coagulating Perforated Resector 26FR For Use With ACMI USA/Elite Resectoscope(26FR) FDA UDI
Identifiers
- Catalog Number
- PR-2600-AC FDA UDI
- Primary DI / UDI-DI
- 00827002462472 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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: Electrosurgical system generator
Cook by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical system generator.
- LEEP PRECISION™ Generator — CooperSurgical, Inc. · Class II
- AEXTM — MEDTRONIC, INC. · Class II
- Endovapor® — JOIMAX, INC. · Class II
- WEREWOLF — Smith & Nephew, Inc. · Class II
- PerFect TCS — Coltene/Whaledent Inc. · Class II
- INTELLIO SHIFT — Smith & Nephew, Inc. · Class II
- Valleylab — Covidien LP · Class II
- VFS1 Generator Main Unit — FHC, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 8fb9ebae-fea4-4b60-a233-81927343d6a2 36 fields · synced Jun 8, 2026