Bovie

FDA UDI

Class II (US FDA UDI)

by Bovie Medical Corporation

Identity

Trade Name: Bovie FDA UDI
Generic Name: Colposcope FDA UDI
Device Name: Colposcope Center Post Tri Power - LED FDA UDI
Model / Reference: CS-305 FDA UDI
Description: Colposcope Center Post Tri Power - LED FDA UDI

Identifiers

Catalog Number: CS-305 FDA UDI
Primary DI / UDI-DI: 10607151011397 FDA UDI
510(k) Number: K073053 FDA UDI
FDA Product Code: HEX FDA UDI
GMDN Term: Colposcope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Colposcope

Bovie by Bovie Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Colposcope.

MICROSCOPE Colposcope — Ecleris · Class II
Henry Schein — HENRY SCHEIN, INC. · Class II
MICROSTAR Colposcope — Ecleris · Class II
Gynex — GYNEX CORPORATION · Class II
MICROSCOPE Colposcope — Ecleris · Class II
WALLACH — CooperSurgical, Inc. · Class II
Henry Schein — HENRY SCHEIN, INC. · Class II
LEISEGANG — CooperSurgical, Inc. · Class II

Cleared under the same submission

K073053 also covers:

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: Bovie Medical Corporation

Sources (1)

FDA UDI 8f2795c5-b2dc-4f4b-af76-147f8560bd13 35 fields · synced Jun 1, 2026