Duns Number:825137818
Device Description: X-Ray Apron w/collar Adult LI/GR
Catalog Number
9507592
Brand Name
Darby Dental Supply, LLC
Version/Model Number
9507592
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
c6908f9d-310e-47f8-a231-e094b1a33fc7
Public Version Date
September 06, 2019
Public Version Number
1
DI Record Publish Date
August 29, 2019
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 | 1457 |
2 | A medical device with a moderate to high risk that requires special controls. | 194 |
U | Unclassified | 2 |