Duns Number:108926288
Catalog Number
-
Brand Name
Nuby
Version/Model Number
6909
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)
Yes
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
b1f50f02-bf9b-43e2-82d2-093ba4cf8d97
Public Version Date
November 02, 2020
Public Version Number
1
DI Record Publish Date
October 23, 2020
Package DI Number
20048526069099
Quantity per Package
4
Contains DI Package
00048526069095
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 |