DEVICE: Planmed (06430035430055)

Device Identifier (DI) Information

Planmed
Sophie Classic
Not in Commercial Distribution

Planmed Oy
06430035430055
GS1
April 17, 2020
1
459718193 *Terms of Use
Planmed Sophie Classic is a mammographic x-ray unit intended for diagnosis of breast cancer.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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GMDN

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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?
37630 Stationary mammographic x-ray system, analogue
An assembly of devices specifically designed to provide a fixed installation (in an imaging facility, or transportation van) x-ray system to compress and image the breast. It is primarily used to optimize the capability of users to visually evaluate x-ray film images representing the anatomy and function of blood and lymphatic vessels within the human breast. It uses analogue or analogue-to-digital conversion techniques for image capture and display. It is used for breast cancer screening and in conjunction with the placement of biopsy markers and stereotactic biopsy and lesion localization equipment requiring x-ray guidance.
Active false
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FDA Product Code

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Product Code Product Code Name
IZH System, X-Ray, Mammographic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1ae19494-ceb5-4673-a73b-b74f694f6379
June 14, 2023
4
September 07, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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