DEVICE: Iotrex® (M74881500)

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Device Record History
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Device Identifier (DI) Information
Iotrex®
8150
In Commercial Distribution

ISORAY MEDICAL, INC.
M74881500
HIBCC

1
113577485 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38412 Brain brachytherapy system applicator, manual
A device specifically designed to be used in radiation therapy treatments of the brain. It has individual or modular device configurations designed to facilitate manual placement, e.g., puncture, endoscopically guided placement or diagnostic imaging guided placement, and removal of single or multiple radioactive sources at a treatment site within the brain. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes brain applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KXK Source, Brachytherapy, Radionuclide
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K111931 000
No CLOSE

Sterilization
Yes
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

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Size Type Text
No Device Sizes
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Device Record Status
aaa9d17f-f459-4f4d-8548-a3da50b6478b
July 06, 2018
3
October 28, 2015
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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
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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