DEVICE: Corning® Med-Gamma ® Glass (03701444300073)
Device Identifier (DI) Information
Corning® Med-Gamma ® Glass
Corning® Med-Gamma ® Glass - 20-24 MM
In Commercial Distribution
CORNING SAS
Corning® Med-Gamma ® Glass - 20-24 MM
In Commercial Distribution
CORNING SAS
Corning® Med-gamma ® Glass is a glass plate that is used for Gamma radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications.
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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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 |
38373 | Radiation shielding panel, portable/mobile |
A portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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KPY | Shield, Protective, Personnel |
IWP | Radiographic Protective Glove |
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
8089c21d-7801-42fe-ae16-a0e7efb1d4f3
September 30, 2022
1
September 22, 2022
September 30, 2022
1
September 22, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined