DEVICE: INTRABEAM® Flat Applicator Set 1.0 cm (04049539101488)

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Device Identifier (DI) Information

INTRABEAM® Flat Applicator Set 1.0 cm
304534-3001-565

Carl Zeiss Meditec AG
04049539101488
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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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
Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator A non-sterile component of an intraoperative/postoperative therapeutic x-ray system designed to be attached to and cover the x-ray source for direct patient contact when the system is used for the treatment of certain clinical conditions (e.g., intra-abdominal tumours). It has a flat distal end that is typically used to irradiate a treatment site while it is exposed surgically during an operation. It is typically supplied in a range of sizes (diameters). This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

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Product Code Product Code Name
JAD System, Therapeutic, X-Ray
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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
Outer Diameter: 1.0 Centimeter
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Device Status

In Commercial Distribution
April 14, 2017

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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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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