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Disposable Distal Attachment

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
DISPOSABLE DISTAL ATTACHMENT FDA UDI
Generic Name
Endoscope distal observation spacer, single-use FDA UDI
Model / Reference
D-201-14304 FDA UDI

Identifiers

Catalog Number
N3529441 FDA UDI
Primary DI / UDI-DI
04953170454349 FDA UDI
510(k) Number
K250296 FDA UDI
FDA Product Code
FDS FDA UDI
FDF FDA UDI
GMDN Term
Endoscope distal observation spacer, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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: Endoscope distal observation spacer, single-use

Disposable Distal Attachment by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope distal observation spacer, single-use.

Cleared under the same submission

K250296 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 de774528-d9e0-4d0f-b21d-64ec261e4799 35 fields · synced Jun 8, 2026