DEVICE: SHIELDED WASTE CONTAINER (00718175000113)

Device Identifier (DI) Information

SHIELDED WASTE CONTAINER
039-110
In Commercial Distribution
039-110
BIODEX MEDICAL SYSTEMS, INC.
00718175000113
GS1

1
043833813 *Terms of Use
Waste Container, Shielded, .25" Lead
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
KPY Shield, Protective, Personnel
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

8c7392ff-2d58-4146-8562-f200793e529b
August 18, 2023
2
May 31, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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