Identity
- Trade Name
- HARMONIC EUDAMEDFDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDI
- Device Name
- HARMONIC Blue Hand Piece EUDAMEDFDA UDI
- Model / Reference
- HARHPBL EUDAMEDFDA UDI
- Description
- HARMONIC BLUE HAND PIECE FDA UDI
Identifiers
- Catalog Number
- HARHPBL FDA UDI
- Primary DI / UDI-DI
- 20705036023446 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a0007779 EUDAMED
- Direct Marketing DI
- 10705036023449 EUDAMED
- 510(k) Number
- K211273 FDA UDI
- FDA Product Code
- LFL FDA UDI
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDU 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Harmonic by Ethicon Endo-Surgery, LLC — Class IIb — 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 | 0705036a0007779 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 5315b7ef-a9aa-434c-8827-5e729f83aee5 61 fields · synced Jun 9, 2026
- FDA UDI f4c1fdba-411a-491a-934a-42bd2701b2eb 37 fields · synced May 30, 2026