DEVICE: Exactrac (04056481000264)

Device Identifier (DI) Information

Exactrac
6.2
In Commercial Distribution
20882-01
Brainlab AG
04056481000264
GS1

1
314482980 *Terms of Use
No description.
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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
Radiological whole-body positioning device A device comprised of fixed or adjustable position elements that is specifically designed to ensure adequate positioning and/or immobilization of the patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures. It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.
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FDA Product Code

[?]
Product Code Product Code Name
IYE Accelerator, Linear, Medical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K120789 000
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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 Record Status

b5471ae7-25bd-4301-9324-93848f0cc884
July 06, 2018
3
September 15, 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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+49899915680
contact@brainlab.com
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