DEVICE: Ru-106 Eye Applicator, type COE 8 MBq (04049223100926)

Device Identifier (DI) Information

Ru-106 Eye Applicator, type COE 8 MBq
RU6.A11
In Commercial Distribution
RU6.A11
Eckert & Ziegler BEBIG GmbH
04049223100926
GS1

1
331080432 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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 [?]
K931393 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Applicators must be stored in a dry state and with sufficient shielding in a locked safe. The Ru-106 eye applicator must not be stored in liquids or in the vicinity of media that promote corrosion.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

88b3a5a2-e830-4226-871f-a7021b51b2ab
July 06, 2018
3
September 24, 2015
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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

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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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+4930941084130
info@bebig.com
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