Duns Number:428561679
Device Description: Disk ø 100 mm. H. 20 Pink
Catalog Number
-
Brand Name
Trilor
Version/Model Number
FDC20PP
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
K173643
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
e59aadad-80c3-4c17-a220-58586f6c1d7c
Public Version Date
September 21, 2021
Public Version Number
1
DI Record Publish Date
September 13, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 104 |