Duns Number:085690428
Device Description: Long Handle Combo Rack
Catalog Number
-
Brand Name
Dentronix
Version/Model Number
D7000CL
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
K051660
Product Code
KMH
Product Code Name
Sterilizer, Dry Heat
Public Device Record Key
4e38a85a-87d2-4128-9244-38b542f5894e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 15, 2016
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. | 16 |