DEVICE: Xstrahl 300 X-Ray System Ceiling (05060494200077)

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Device Identifier (DI) Information

Xstrahl 300 X-Ray System Ceiling
Xstrahl 300 X-Ray System Ceiling

XSTRAHL LIMITED
05060494200077
GS1
1
Xstrahl 300 X-Ray System Ceiling
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Stationary orthovoltage therapeutic x-ray system An assembly of devices designed to produce low-energy x-rays used for therapeutic purposes, primarily in the treatment of skin cancer (e.g., basal cell or squamous cell carcinoma) or other skin conditions (e.g., psoriasis, keloid). The radiation source typically uses a tube voltage of between approximately 100 kV and 500 kV and will be used in conjunction with a variety of topical applicators. The main system is ceiling- or wall-mounted (fixed) in a radiotherapy suite or other clinical setting.
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FDA Product Code

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Product Code Product Code Name
JAD System, Therapeutic, X-Ray
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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 Status

In Commercial Distribution
January 27, 2017

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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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