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Harmonic Focus

FDA UDI

Class U (US FDA UDI)

by Ethicon Endo-Surgery, Inc.

Identity

Trade Name
Harmonic Focus FDA UDI
Generic Name
Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI
Device Name
Harmonic Focus Curved Shears Torque Wrench and Grip Assist Long for use with Blue Hand Piece Only FDA UDI
Model / Reference
FCS9 FDA UDI
Description
Harmonic Focus Curved Shears Torque Wrench and Grip Assist Long for use with Blue Hand Piece Only FDA UDI

Identifiers

Catalog Number
FCS9 FDA UDI
Primary DI / UDI-DI
10705036001959 FDA UDI
FDA Product Code
LFL FDA UDI
GMDN Term
Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI

Classification

Device Class
U 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 Focus by Ethicon Endo-Surgery, Inc. — Class U — 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 93c3f902-35cf-416b-99b4-79198c635c22 36 fields · synced Jun 1, 2026