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Zinnanti Surgical

FDA UDI

Class II (US FDA UDI)

by Zinnanti Surgical Design Group Inc

Identity

Trade Name
Zinnanti Surgical FDA UDI
Generic Name
Electrosurgical handpiece, single-use FDA UDI
Device Name
Smoke-Evac Fusion Electrosurgical Pencil II-with Extended Cap & 2" Teflon Blade FDA UDI
Model / Reference
14-2001 FDA UDI
Description
Smoke-Evac Fusion Electrosurgical Pencil II-with Extended Cap & 2" Teflon Blade FDA UDI

Identifiers

Catalog Number
14-2001 FDA UDI
Primary DI / UDI-DI
G3731420010 FDA UDI
510(k) Number
K092634 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Electrosurgical handpiece, 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

Yes

FDA UDI

Category: Electrosurgical handpiece, single-use

Zinnanti Surgical by Zinnanti Surgical Design Group Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrosurgical handpiece, single-use.

Cleared under the same submission

K092634 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zinnanti Surgical Design Group Inc

Sources (1)

  • FDA UDI b803dcd0-2bcb-44a6-ba65-2b189c6663a2 35 fields · synced May 31, 2026