Identity
- Trade Name
- HARMONIC EUDAMEDFDA UDI
- Generic Name
- Ultrasonic surgical system torque wrench, reusable FDA UDI
- Device Name
- HARMONIC Blade Wrench EUDAMEDHarmonic Torque Lock Blade Wrench FDA UDI
- Model / Reference
- TLB01 EUDAMEDFDA UDI
- Description
- Harmonic Torque Lock Blade Wrench FDA UDI
Identifiers
- Catalog Number
- TLB01 FDA UDI
- Primary DI / UDI-DI
- 10705036003113 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000226G EUDAMED
- Direct Marketing DI
- 10705036003113 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Ultrasonic surgical system torque wrench, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
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 | 0705036a000226G | 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 b999e677-eae8-46c3-9a96-8f49d6a7b6af 61 fields · synced Jun 9, 2026
- FDA UDI 76e746d0-c29e-4480-b9cf-ec9c5c1e1b2e 36 fields · synced May 30, 2026