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Reference Plate

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
REFERENCE PLATE FDA UDI
Generic Name
Electromagnetic endoscope tracking system reference transmitter, external, body-surface FDA UDI
Device Name
MAJ-1860 ScopeGuide Reference Plate FDA UDI
Model / Reference
MAJ-1860 FDA UDI
Description
MAJ-1860 ScopeGuide Reference Plate FDA UDI

Identifiers

Primary DI / UDI-DI
04953170305672 FDA UDI
510(k) Number
K103312 FDA UDI
FDA Product Code
FDF FDA UDI
GMDN Term
Electromagnetic endoscope tracking system reference transmitter, external, body-surface 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI

Category: Electromagnetic endoscope tracking system reference transmitter, external, body-surface

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

Similar devices

Also classified as Electromagnetic endoscope tracking system reference transmitter, external, body-surface.

Cleared under the same submission

K103312 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 e14ee8a3-df5c-451f-abd9-77027373759a 35 fields · synced May 30, 2026