DEVICE: SagiNova®, HDR Afterloader, 25 channels, for Co-60 and Ir-192 (04049223114961)
Device Identifier (DI) Information
SagiNova®, HDR Afterloader, 25 channels, for Co-60 and Ir-192
1321-0201
Not in Commercial Distribution
1321-0201
Eckert & Ziegler BEBIG GmbH
1321-0201
Not in Commercial Distribution
1321-0201
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© 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? |
---|---|---|---|---|
38300 | Remote-afterloading brachytherapy system |
An assembly of devices using a remotely-controlled radioactive source transport system designed to deliver a therapeutic or palliative radiation dose from a single source or source train to an anatomical region by placing the radioactive source(s) temporarily on or in the treatment site. A standard system consists of 1) a single radioactive source or source train in various forms; 2) a shielded vault to hold the sources when not used; 3) guide tubes/catheters to remotely direct the sources to the treatment site; 4) a remote-controlled mechanism to move the sources inside the guide tubes/catheters; 5) applicators; 6) computer treatment planning programs; and 7) an operator's console.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JAQ | System, Applicator, Radionuclide, Remote-Controlled |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f548a226-0f60-46b3-b95e-07b1d0734e94
February 29, 2024
4
October 04, 2016
February 29, 2024
4
October 04, 2016
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