Identity
- Trade Name
- EnergyShield Monopolar Cautery Cord EUDAMEDEnergyShield FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- EnergyShield Monopolar Cautery Cord EUDAMEDMONOPOLAR CAUTERY CORD FDA UDI
- Model / Reference
- 430068 EUDAMEDFDA UDI
- Description
- MONOPOLAR CAUTERY CORD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00886874115671 EUDAMEDFDA UDI
- Basic UDI-DI
- 08868741229909C EUDAMED
- Direct Marketing DI
- 00886874115671 EUDAMED
- FDA Product Code
- NAY FDA UDI
- EMDN Code
- L1399 ROBOTIC SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
No
Manufacturing Date
No
Category: Electrical-only medical device connection cable, reusable
EnergyShield by Intuitive Surgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Intuitive Surgical, Inc.
Sources (2)
- FDA UDI 4aadaf8b-7c09-495c-8b88-21bd6d378f9d 33 fields · synced Jul 25, 2026
- EUDAMED 0fda6103-be31-4baa-b60d-2f97d9ca281c 61 fields · synced Jul 25, 2026