DEVICE: TABLETOP SHIELD (00718175002278)
Device Identifier (DI) Information
TABLETOP SHIELD
042-227
In Commercial Distribution
042-227
BIODEX MEDICAL SYSTEMS, INC.
042-227
In Commercial Distribution
042-227
BIODEX MEDICAL SYSTEMS, INC.
Shield, Tabletop, Side, .25" Lead
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| 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. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 38374 | Radiation shielding panel, fixed |
A permanently installed device forming a structural barrier designed to block or attenuate radiation emissions from a primary or scattered radiation source. It includes various solid or transparent barriers typically used to shield patients from unnecessary exposure to radiation emitted from, e.g., diagnostic/therapeutic radiation emitting devices. It may also be used to shield a patient undergoing a diagnostic or therapeutic procedure requiring the administration of a radioactive material or placement of a radioactive source. The barrier can be permanently attached to the floor, wall or ceiling or to a medical device, or mounted on articulating structures giving a limited range of motion.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KPY | Shield, Protective, Personnel |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
c1d69aa4-8e06-4d70-b1f5-5b46f2a89ac0
June 10, 2019
1
May 31, 2019
June 10, 2019
1
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 |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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