Duns Number:808695159
Catalog Number
90-2026S
Brand Name
Extended Worktop - Self-Contained Carts
Version/Model Number
90-2026S
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
K110481
Product Code
EIA
Product Code Name
Unit, Operative Dental
Public Device Record Key
d3809bde-6d0d-4aaa-88c0-123fc249e197
Public Version Date
August 02, 2019
Public Version Number
1
DI Record Publish Date
July 25, 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 | 49 |