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Olympus

FDA UDI

Class II (US FDA UDI)

by Keymed (Medical & Industrial Equipment), Ltd.

Identity

Trade Name
Olympus FDA UDI
Generic Name
Endoscope distal observation spacer, single-use FDA UDI
Model / Reference
ARV140 FDA UDI

Identifiers

Catalog Number
K10037619 FDA UDI
Primary DI / UDI-DI
15019778008684 FDA UDI
FDA Product Code
FED 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

Yes

FDA UDI

Category: Endoscope distal observation spacer, single-use

Olympus by Keymed (Medical & Industrial Equipment), Ltd. — 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
Keymed (Medical & Industrial Equipment), Ltd.

Sources (1)

  • FDA UDI 923768fb-7694-4944-910d-28074930360b 33 fields · synced Jun 6, 2026