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Single Use Cytology Brush BC-205D

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
Single Use Cytology Brush BC-205D FDA UDI
Generic Name
Flexible endoscopic cytology brush, single-use FDA UDI
Device Name
Single Use Cytology Brush BC-205D FDA UDI
Model / Reference
BC-205D-2010 FDA UDI
Description
Single Use Cytology Brush BC-205D FDA UDI

Identifiers

Catalog Number
N5767440 FDA UDI
Primary DI / UDI-DI
04953170401961 FDA UDI
510(k) Number
K212667 FDA UDI
FDA Product Code
EOQ FDA UDI
BTG FDA UDI
GMDN Term
Flexible endoscopic cytology brush, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4680 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

No

FDA UDI

Category: Flexible endoscopic cytology brush, single-use

Single Use Cytology Brush BC-205D by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible endoscopic cytology brush, single-use.

Cleared under the same submission

K212667 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI 186c68bb-9721-4eca-a4d0-0d1e90125930 36 fields · synced Jun 1, 2026