DEVICE: Summit (B307S1110)

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Device Identifier (DI) Information

Summit
S111
S111
SUMMIT INDUSTRIES, LLC
B307S1110
HIBCC
1
RADIOGRAPHIC IMAGE RECEPTOR STAND
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
X-ray film cassette holder A device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).
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FDA Product Code

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Product Code Product Code Name
IXY Holder, Radiographic Cassette, Wall-Mounted
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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
Handling Environment Atmospheric Pressure: between 10 and 40 Degrees Celsius
Special Storage Condition, Specify: Keep dry
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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
November 01, 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

[?]
+1773-353-4000
villih@summitindustries.Net
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