superDimension

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: superDimension FDA UDI
Generic Name: Flexible endoscopic cytology brush, single-use FDA UDI
Device Name: Needle-tipped Cytology Brush; Aspirating Port FDA UDI
Model / Reference: SDNB2000 FDA UDI
Description: Needle-tipped Cytology Brush; Aspirating Port FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521200531 FDA UDI
FDA Product Code: FDX FDA UDI
GAA FDA UDI
GMDN Term: Flexible endoscopic cytology brush, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
878.4800 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

Yes

FDA UDI

Category: General-purpose endoscopic needle, single-use Flexible endoscopic cytology brush, single-use

superDimension by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
DISPOSABLE CYTOLOGY BRUSH — Olympus Medical Systems Corporation · Class II
CONMED — Conmed Corporation · Class II
EndoTBrush Cytology Brush — ENDO-THERAPEUTICS, INC. · Class II
Disposable Bronchial Cytology Brush — TeleMed Systems · Class II
CONMED — Conmed Corporation · Class II
CONMED — Conmed Corporation · Class I
DISPOSABLE CYTOLOGY BRUSH — Olympus Medical Systems Corporation · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Covidien LP

Sources (1)

FDA UDI 2e129797-855e-498d-b908-5d0f5961af56 35 fields · synced May 30, 2026