DEVICE: INTRABEAM® Needle Applicator (04049539101372)

Device Identifier (DI) Information

INTRABEAM® Needle Applicator
304534-3001-200
In Commercial Distribution

Carl Zeiss Meditec AG
04049539101372
GS1

1
342228620 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Intraoperative/postoperative therapeutic x-ray system needle applicator A sterile needle-shaped component of an intraoperative/postoperative therapeutic x-ray system designed to be attached to and cover the x-ray source when the system is used for the treatment of certain clinical conditions, typically tumours in narrow cavities (e.g., brain, spine). The device is in direct contact with the patient and is typically used intraoperatively within a resected (e.g., brain) tumour bed. This is a single-use device.
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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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K110590 000
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Sterilization

Yes
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

844d8e09-a07e-4553-924d-b4d261d36bc8
July 06, 2018
3
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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Yes
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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