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Leakage Tester

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
LEAKAGE TESTER FDA UDI
Generic Name
Invasive medical device leak tester, electrical FDA UDI
Device Name
"MB-155 LEAKAGE TESTER FOR MU-1" FDA UDI
Model / Reference
MB-155 FDA UDI
Description
"MB-155 LEAKAGE TESTER FOR MU-1" FDA UDI

Identifiers

Catalog Number
GX9381 FDA UDI
Primary DI / UDI-DI
04953170065163 FDA UDI
FDA Product Code
FDS FDA UDI
FDF FDA UDI
NWB FDA UDI
GMDN Term
Invasive medical device leak tester, electrical 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Invasive medical device leak tester, electrical

Leakage Tester by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Invasive medical device leak tester, electrical.

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 a47a39c9-880b-45bc-9bf9-c885cffeff42 35 fields · synced May 31, 2026