Identity
- Trade Name
- HARMONIC EUDAMEDHarmonic ACE FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI
- Device Name
- HARMONIC ACE+7 Shears EUDAMEDHarmonic ACE +7 Laparoscopic Shears Advanced Hemostasis 5mm Diameter 45cm Shaft length For Use With Gray Hand Piece Only FDA UDI
- Model / Reference
- HARH45 EUDAMEDFDA UDI
- Description
- Harmonic ACE +7 Laparoscopic Shears Advanced Hemostasis 5mm Diameter 45cm Shaft length For Use With Gray Hand Piece Only FDA UDI
Identifiers
- Catalog Number
- HARH45 FDA UDI
- Primary DI / UDI-DI
- 10705036014638 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000146H EUDAMED
- FDA Product Code
- LFL FDA UDI
- EMDN Code
- K0202010601,K0202010602 EUDAMED
- GMDN Term
- Soft-tissue ultrasonic surgical system handpiece tip, single-use 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
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
Yes
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 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 | 0705036a000146H | 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 ce3a719b-9ac5-45e9-8b9b-744bbd94bfe6 61 fields · synced Aug 1, 2026
- FDA UDI 18851a8e-5139-4a57-b048-da1547c352c1 36 fields · synced May 30, 2026