DEVICE: Universal Leveling Template, 10X10 (B36511268040)

Device Identifier (DI) Information

Universal Leveling Template, 10X10
11-268-04
In Commercial Distribution

Aktina Corp.
B36511268040
HIBCC

1
787178920 *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

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

GMDN Preferred Term Name GMDN Definition
Radiation therapy beam block production plate A dedicated device, a dish, used for the manual production of beam blocks which serve to configure a radiation field. This device is used in the production of radiotherapy blocks to cool down the melted metal, e.g., Rose's metal [consisting of lead (Pb), tin (Sn) and bismuth] when this has been poured into the moulds. It may also have the function of vibrating the metal during the cooling process to ensure equal distribution of the metal throughout the mould.
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FDA Product Code

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Product Code Product Code Name
IXI Block, Beam-Shaping, Radiation Therapy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K973953 000
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

395d924f-032f-49da-8b9c-6d1bfbb3b7a7
July 06, 2018
3
September 27, 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
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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