DEVICE: CellaVision® Remote Review Software version 5.0.x, Non-expiring license (07350040973714)

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Device Identifier (DI) Information

CellaVision® Remote Review Software version 5.0.x, Non-expiring license
CRRS-005099
CRRS-005099
Cellavision AB
07350040973714
GS1
1
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
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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
Laboratory analyser application software IVD An individual software program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to an analyser or an analyser system. A basic set of applications programs and routines is included with such computer-controlled analysers and they can be modified or upgraded to correct programming errors or to add new analyser/system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
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FDA Product Code

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Product Code Product Code Name
JOY Device, Automated Cell-Locating
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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 23, 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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+46462864400
info@cellavision.com
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