DEVICE: Compass International (B169TP300)

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Device Record History
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Device Identifier (DI) Information
Compass International
TP-30
In Commercial Distribution
TP-30
Compass International
B169TP300
HIBCC

1
809466410 *Terms of Use
Cygnus Test Phantom
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
40616 Multi-modality diagnostic imaging phantom, test object
A device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations and is a quality assurance device used in both subjective and quantitative evaluations of various calibration and performance characteristics of diagnostic imaging systems. A multi-modality phantom is specifically intended for use with more than one diagnostic imaging modality, e.g., magnetic resonance imaging (MRI), ultrasound, x-ray and nuclear medicine (NM) systems.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HAW Neurological Stereotaxic Instrument
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
44359945-080b-4052-aa60-f197cc5d3e6a
March 29, 2018
2
August 26, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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