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Ace-Tip Electrode

FDA UDI

Class II (US FDA UDI)

by Cynosure, LLC

Identity

Trade Name
Ace-Tip Electrode FDA UDI
Generic Name
Open-surgery electrosurgical electrode, monopolar, reusable FDA UDI
Device Name
5MM TAPERED BALL ACE-TIP 1/16", BENDABLE FDA UDI
Model / Reference
TNAD13B FDA UDI
Description
5MM TAPERED BALL ACE-TIP 1/16", BENDABLE FDA UDI

Identifiers

Catalog Number
TNAD13B FDA UDI
Primary DI / UDI-DI
00841494101763 FDA UDI
510(k) Number
K071343 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery electrosurgical electrode, monopolar, reusable 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Open-surgery electrosurgical electrode, monopolar, reusable

Ace-Tip Electrode by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery electrosurgical electrode, monopolar, reusable.

Cleared under the same submission

K071343 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cynosure, LLC

Sources (1)

  • FDA UDI c7385922-f4fb-44dd-b405-9422c4f44fa4 35 fields · synced May 30, 2026