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
03701444300073
GS1

1
737387944 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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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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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FDA Product Code

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Product Code Product Code Name
KPY Shield, Protective, Personnel
IWP Radiographic Protective Glove
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FDA Premarket Submission

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

No
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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

8089c21d-7801-42fe-ae16-a0e7efb1d4f3
September 30, 2022
1
September 22, 2022
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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
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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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Yes
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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