Identity
- Trade Name
- HARMONIC EUDAMEDFDA UDI
- Generic Name
- Ultrasonic surgical system adaptor, reusable FDA UDI
- Device Name
- HARMONIC/ENSEAL Generator Connector EUDAMEDHarmonic Generator Connector FDA UDI
- Model / Reference
- HGA11 EUDAMEDFDA UDI
- Description
- Harmonic Generator Connector FDA UDI
Identifiers
- Catalog Number
- HGA11 FDA UDI
- Primary DI / UDI-DI
- 20705036013997 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000206C EUDAMED
- Direct Marketing DI
- 10705036013990 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Ultrasonic surgical system adaptor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Harmonic by Ethicon Endo-Surgery, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705036a000206C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED 48898b8f-98f1-4b08-a914-e5d27dbc5420 61 fields · synced Jun 9, 2026
- FDA UDI e90ba96c-8f8c-429d-8205-a9dae0a59bab 36 fields · synced May 30, 2026