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Reciver Dish

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
RECIVER DISH FDA UDI
Generic Name
Gastrointestinal catheter/endoscope tracking system sensor, bedside FDA UDI
Device Name
MAJ-1868 ScopeGuide Receiver Dish FDA UDI
Model / Reference
MAJ-1868 FDA UDI
Description
MAJ-1868 ScopeGuide Receiver Dish FDA UDI

Identifiers

Primary DI / UDI-DI
04953170305689 FDA UDI
510(k) Number
K103312 FDA UDI
FDA Product Code
FDF FDA UDI
GMDN Term
Gastrointestinal catheter/endoscope tracking system sensor, bedside 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

Category: Gastrointestinal catheter/endoscope tracking system sensor, bedside

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

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 12e041cd-3d85-43a3-93b4-69534267d373 35 fields · synced Jun 8, 2026