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Harmonic LaparaSonic

FDA UDI

Class II (US FDA UDI)

by Ethicon Endo-Surgery, Inc.

Identity

Trade Name
Harmonic LaparaSonic FDA UDI
Generic Name
Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI
Device Name
Harmonic LaparaSonic Ball Coagulators 5mm FDA UDI
Model / Reference
HBC05 FDA UDI
Description
Harmonic LaparaSonic Ball Coagulators 5mm FDA UDI

Identifiers

Catalog Number
HBC05 FDA UDI
Primary DI / UDI-DI
10705036002062 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Soft-tissue ultrasonic surgical system handpiece tip, single-use

Harmonic LaparaSonic by Ethicon Endo-Surgery, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Soft-tissue ultrasonic surgical system handpiece tip, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, Inc.

Sources (1)

  • FDA UDI c89a304c-3f90-434b-b44c-3c53c930bb4b 36 fields · synced May 30, 2026