DEVICE: Leksell Gamma Knife Perfexion/Icon (07340048307963)

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Device Identifier (DI) Information

Leksell Gamma Knife Perfexion/Icon
1049544

Elekta Instrument AB
07340048307963
GS1
1
FRAME FIXATION ADAPTER
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Device Characteristics

MR Unsafe
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
Teletherapy radionuclide system An assembly of devices that deliver a therapeutic radiation dose to an anatomical region from a single external radiation beam produced by a radionuclide source. A typical system is: 1) the treatment head (a shielded source vault containing a single radioactive source located in a moveable housing); 2) a rotating or fixed gantry with the treatment head at one end and a counter weight functioning as a beam stop on the other; 3) a collimator mechanism attached to the gantry to align the treatment beam; 4) a moveable patient table used to align and position the patient in the radiation beam; and 5) an operator's console containing the controls. It is commonly known as a cobalt therapy machine.
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FDA Product Code

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Product Code Product Code Name
IWB System, radiation therapy, radionuclide
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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 Status

In Commercial Distribution
September 24, 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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(855)693-5358
info.america@elekta.com
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