DEVICE: SHIELDED WASTE CONTAINER (00718175000113)
Device Identifier (DI) Information
SHIELDED WASTE CONTAINER
039-110
In Commercial Distribution
039-110
BIODEX MEDICAL SYSTEMS, INC.
039-110
In Commercial Distribution
039-110
BIODEX MEDICAL SYSTEMS, INC.
Waste Container, Shielded, .25" Lead
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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35430 | Radioactive waste container |
A hard-walled container designed for the safe deposit, collection and storage of radioactive materials including containers previously used for those materials (e.g., scintillation vials). It is made from metal and/or hard plastic and typically designed with an internal radiation shield [e.g., a lead (Pb) liner]. It typically has a lid with radiation shielding properties that allows temporary and final closure options. It is identified with a radioactive symbol on its labelling and sent to a radioactive waste treatment plant for disposal when filled to the recommended level.
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FDA Product Code
[?]Product Code | Product Code Name |
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KPY | Shield, Protective, Personnel |
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
8c7392ff-2d58-4146-8562-f200793e529b
August 18, 2023
2
May 31, 2019
August 18, 2023
2
May 31, 2019
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
[?]
No Customer Contact currently defined