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Systems Integration Endoalpha

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
SYSTEMS INTEGRATION ENDOALPHA FDA UDI
Generic Name
Operating room audiovisual data/device management system application software FDA UDI
Model / Reference
MAJ-2528 FDA UDI

Identifiers

Primary DI / UDI-DI
04953170435201 FDA UDI
FDA Product Code
GCJ FDA UDI
ODA FDA UDI
GMDN Term
Operating room audiovisual data/device management system application software 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Operating room audiovisual data/device management system application software

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

Similar devices

Also classified as Operating room audiovisual data/device management system application software.

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 08b9b978-6115-40a2-a786-503517294f50 33 fields · synced May 30, 2026