Duns Number:108926288
Catalog Number
-
Brand Name
Nuby
Version/Model Number
509
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
KKO
Product Code Name
Ring, Teething, Fluid-Filled
Public Device Record Key
8386c25b-89dd-435c-8d56-7507b8d833c5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 01, 2016
Package DI Number
50048526005098
Quantity per Package
12
Contains DI Package
40048526005091
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 12 |