DEVICE: Advantage I-125® (M936IRLS07SSS0)

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Device Record History
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Device Identifier (DI) Information
Advantage I-125®
RSLN-7
In Commercial Distribution

ISOAID, L.L.C.
M936IRLS07SSS0
HIBCC

1
002751241 *Terms of Use
Radioactive Seed Localization Needle with I-125 seed, spacer, strand
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Device Characteristics
MR Conditional
No
No
Yes
No
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?
38304 Manual brachytherapy source, temporary placement
A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope in a form that is intended for temporary placement in the body and removal after a specified treatment time. It is used in brachytherapy applications that require direct manual or endoscopically-guided placement and removal. Manually inserted sources intended for temporary placement come in a variety of forms, e.g., encapsulated, sealed, plated, foil or embedded sources. It can be inserted directly into the patient or be implanted using catheters or applicators and may take the form of needles, spheres, ovoids, seeds, wires or liquids included in the cuffed portion of a catheter.
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 [?]
K141701 000
No CLOSE

Sterilization
Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
48127f00-24f0-44af-902d-ab86e491ac8d
July 06, 2018
3
February 04, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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