Duns Number:737387944
Device Description: Corning® Med-gamma ® Glass is a glass plate that is used for Gamma radiation attenuation. 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.
Catalog Number
-
Brand Name
Corning® Med-Gamma ® Glass
Version/Model Number
Corning® Med-Gamma ® Glass - 32-36 MM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IWP
Product Code Name
Radiographic Protective Glove
Public Device Record Key
b1b1a7bd-c6fe-47e7-8849-c4d41a593246
Public Version Date
September 30, 2022
Public Version Number
1
DI Record Publish Date
September 22, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 26 |