Bovie

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: Bovie FDA UDI
Generic Name: Electrosurgical return electrode, single-use FDA UDI
Device Name: Extended Blade Electrode 6” (15.24 cm) Non-Stick (10/PK) FDA UDI
Model / Reference: 568604 FDA UDI
Description: Extended Blade Electrode 6” (15.24 cm) Non-Stick (10/PK) FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925008083 FDA UDI
510(k) Number: K950455 FDA UDI
FDA Product Code: JOS FDA UDI
GMDN Term: Electrosurgical return electrode, 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrosurgical return electrode, single-use

Bovie by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K950455 also covers:

Bovie — Gyrus Acmi, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Gyrus Acmi, Inc.

Sources (1)

FDA UDI 30563551-e3ee-46a6-976e-4921d1510e2f 34 fields · synced Jun 8, 2026