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Bovie

FDA UDI

Class II (US FDA UDI)

by Symmetry Surgical Inc.

Identity

Trade Name
Bovie FDA UDI
Generic Name
Electrocautery system generator, battery-powered FDA UDI
Device Name
Power Handle Low-Temp FDA UDI
Model / Reference
HIT0 FDA UDI
Description
Power Handle Low-Temp FDA UDI

Identifiers

Primary DI / UDI-DI
00887482181300 FDA UDI
510(k) Number
K840434 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Electrocautery system generator, battery-powered 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: Electrocautery system generator, battery-powered

Bovie by Symmetry Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocautery system generator, battery-powered.

Cleared under the same submission

K840434 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Symmetry Surgical Inc.

Sources (1)

  • FDA UDI 834910fe-3b33-41e8-b4a3-990e4821d8d3 36 fields · synced May 30, 2026