Duns Number:108926288
Catalog Number
-
Brand Name
Nuby
Version/Model Number
624
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
1a9e2c2c-d488-4245-aae5-409d30222e65
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 06, 2016
Package DI Number
60048526006245
Quantity per Package
4
Contains DI Package
40048526006241
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 |