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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-201-12402 FDA UDI

Identifiers

Catalog Number
N6194940 FDA UDI
Primary DI / UDI-DI
04953170453861 FDA UDI
FDA Product Code
FDS 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

No

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
Sterilization Method
Ethylene Oxide 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.

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 c2d6c47d-fc2c-434e-9d5a-ef26cb879c69 34 fields · synced May 30, 2026