Duns Number:010016319
Device Description: Adult Panoramic No Lead Apron .25mm 24" X 27" Black
Catalog Number
-
Brand Name
Adult Panoramic Apron .25mm 24" X 27"
Version/Model Number
75061NL-25
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"
-
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
IWO
Product Code Name
Apron, Protective
Public Device Record Key
7560b796-4c01-4c77-a1a5-1c7768d3d532
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
March 20, 2020
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 | 3215 |