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Central Archive module

FDA UDI

Class II (US FDA UDI)

by Orpheus Medical Ltd

Identity

Trade Name
Central Archive module FDA UDI
Generic Name
Radiology picture archiving and communication system digital archive device FDA UDI
Model / Reference
01 FDA UDI

Identifiers

Catalog Number
MAU-EG20001 FDA UDI
Primary DI / UDI-DI
07290017025087 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiology picture archiving and communication system digital archive device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Radiology picture archiving and communication system digital archive device

Central Archive module by Orpheus Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology picture archiving and communication system digital archive device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orpheus Medical Ltd

Sources (1)

  • FDA UDI 4cd8ad5c-626e-4fa0-bd72-131e8b0f95d0 33 fields · synced Jun 6, 2026