DEVICE: Ru-106 Eye Applicator with slot, type CCB 19 MBq (04049223100858)
Device Identifier (DI) Information
Ru-106 Eye Applicator with slot, type CCB 19 MBq
RU6.A06-S
Not in Commercial Distribution
RU6.A06-S
Eckert & Ziegler BEBIG GmbH
RU6.A06-S
Not in Commercial Distribution
RU6.A06-S
Eckert & Ziegler BEBIG GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
No | |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KXK | Source, Brachytherapy, Radionuclide |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K931393 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
06426bcd-5940-48d4-81cf-338f2fb98f6f
July 01, 2020
4
September 24, 2015
July 01, 2020
4
September 24, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4930941084130
info@bebig.com
info@bebig.com