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Compass International

FDA UDI

Class II (US FDA UDI)

by Compass International

Identity

Trade Name
Compass International FDA UDI
Generic Name
Multi-modality diagnostic imaging phantom, test object FDA UDI
Device Name
Cygnus Test Phantom FDA UDI
Model / Reference
TP-30 FDA UDI
Description
Cygnus Test Phantom FDA UDI

Identifiers

Catalog Number
TP-30 FDA UDI
Primary DI / UDI-DI
B169TP300 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Multi-modality diagnostic imaging phantom, test object FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-modality diagnostic imaging phantom, test object

Compass International by Compass International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-modality diagnostic imaging phantom, test object.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Compass International

Sources (1)

  • FDA UDI 44359945-080b-4052-aa60-f197cc5d3e6a 34 fields · synced May 30, 2026