Duns Number:794759212
Device Description: Dental CONTAINER - BOTTOM PERFORATED 310X190X80MM
Catalog Number
-
Brand Name
BAHADIR USA
Version/Model Number
Y 511.08A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K131407
Product Code
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
2a985d70-1086-43bf-9a05-83502fefb56e
Public Version Date
July 08, 2021
Public Version Number
6
DI Record Publish Date
February 17, 2017
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 | 296 |
2 | A medical device with a moderate to high risk that requires special controls. | 550 |