Duns Number:131904450
Device Description: Cooling Teether-Clear-3mo+
Catalog Number
222341
Brand Name
Green Sprouts
Version/Model Number
222341-920-33
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
K093370,K093370,K093370
Product Code
KKO
Product Code Name
Ring, Teething, Fluid-Filled
Public Device Record Key
e596d768-8dab-4100-89e3-d376a178c4c3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 23, 2016
Package DI Number
30715418020359
Quantity per Package
2
Contains DI Package
20715418020352
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 53 |
2 | A medical device with a moderate to high risk that requires special controls. | 11 |