Identity
- Trade Name
- HARMONIC EUDAMEDFDA UDI
- Generic Name
- Ultrasonic surgical system adaptor, single-use FDA UDI
- Device Name
- HARMONIC Hand Switching Adaptor EUDAMEDHarmonic Disposable Hand Switching Adaptors FDA UDI
- Model / Reference
- HSA08 EUDAMEDFDA UDI
- Description
- Harmonic Disposable Hand Switching Adaptors FDA UDI
Identifiers
- Catalog Number
- HSA08 FDA UDI
- Primary DI / UDI-DI
- 10705036011934 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000166M EUDAMED
- FDA Product Code
- LFL FDA UDI
- EMDN Code
- Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Ultrasonic surgical system adaptor, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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 | 0705036a000166M | 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 49931f06-513e-4c60-a671-975cd7e6c133 61 fields · synced Jun 9, 2026
- FDA UDI 39e2c72b-6c39-433f-b669-fd9cbaf9ac30 36 fields · synced May 27, 2026