DEVICE: Ru-106 Eye Applicator, type CCB 19 MBq (04049223100834)
Device Identifier (DI) Information
Ru-106 Eye Applicator, type CCB 19 MBq
RU6.A06
In Commercial Distribution
RU6.A06
Eckert & Ziegler BEBIG GmbH
RU6.A06
In Commercial Distribution
RU6.A06
Eckert & Ziegler BEBIG GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
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. |
FDA Product Code
[?]Product Code | Product Code Name |
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KXK | Source, Brachytherapy, Radionuclide |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
6410934e-1079-417e-b3eb-93b7af25d2d1
March 29, 2018
2
September 24, 2015
March 29, 2018
2
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 |
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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