Identity
- Trade Name
- EndoGuidace ESU Button Pencil FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
- Device Name
- MD-ESU-D006 Electro Surgical Pencil, PTFE Coated Tips, With Holster FDA UDI
- Model / Reference
- MD-ESU-D006 FDA UDI
- Description
- MD-ESU-D006 Electro Surgical Pencil, PTFE Coated Tips, With Holster FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810143451474 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
EndoGuidace ESU Button Pencil by Medical Disposables Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar.
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- ElectrodeCRF — Cambridge Interventional LLC · Class II
- BIG-TIP™ — RF Medical Co., Ltd. · Class II
- ElectrodeCRF — Cambridge Interventional LLC · Class II
- MYOBLATE — RF Medical Co., Ltd. · Class II
- BIG-TIP™ — RF Medical Co., Ltd. · Class II
- Big-Tip — RF Medical 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
- Medical Disposables Corp
Sources (1)
- FDA UDI 11d428e8-ffdf-42fa-8599-0cf466cae3b7 33 fields · synced May 30, 2026