DEVICE: Integrity™ (05060191071062)

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Device Identifier (DI) Information

Integrity™
1526754

ELEKTA LIMITED
05060191071062
GS1
1
Integrity
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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
Accelerator system computer A dedicated mainframe computer, personal computer (PC) or PC based platform and associated hardware, firmware, and operating system software used specifically to control and monitor the operation of a linear or non-linear medical accelerator system and associated processing, display and analysis functions.
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FDA Product Code

[?]
Product Code Product Code Name
IYE Accelerator, linear, medical
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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 Status

In Commercial Distribution
September 24, 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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(855)693-5358
systems.support.na@elekta.com
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