DEVICE: Summit (B307S2030)

Device Identifier (DI) Information

Summit
S203
In Commercial Distribution
S203
SUMMIT INDUSTRIES, LLC
B307S2030
HIBCC

1
130235187 *Terms of Use
RADIOGRAPHIC TUBESTAND
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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 system tube support, floor stand A floor stand is a hardware assembly with its related mechanical, electronic or software controls that form the structure used to mount, support and facilitate positioning of the x-ray tube assembly sub-system of either a diagnostic x-ray system, therapeutic x-ray system, or an x-ray system designed for use as a radiation therapy simulator. Typically mobile, some designs also support and coordinate the movement and positioning of a radiographic cassette or image receptor assembly with respect to the position of the x-ray tube, e.g., a C-arm assembly. It is considered to be a component of a x-ray system.
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FDA Product Code

[?]
Product Code Product Code Name
IYB Tube Mount, X-Ray, Diagnostic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
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

[?]
Size Type Text
No Device Sizes
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Device Record Status

04077cbc-b5a6-463a-8f41-00843d7556b5
March 29, 2018
2
November 07, 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

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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

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