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Connection Unit

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
CONNECTION UNIT FDA UDI
Generic Name
Gastrointestinal catheter/endoscope tracking system FDA UDI
Device Name
MAJ-1928 ScopeGuide Connection Unit FDA UDI
Model / Reference
MAJ-1928 FDA UDI
Description
MAJ-1928 ScopeGuide Connection Unit FDA UDI

Identifiers

Primary DI / UDI-DI
04953170305795 FDA UDI
510(k) Number
K103312 FDA UDI
FDA Product Code
FDF FDA UDI
GMDN Term
Gastrointestinal catheter/endoscope tracking system 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

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

Similar devices

Also classified as Gastrointestinal catheter/endoscope tracking system.

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 7fe1355b-0772-46a1-8e7a-a6ecad6faf8f 35 fields · synced May 30, 2026