Duns Number:131904450
Catalog Number
-
Brand Name
Green Sprouts
Version/Model Number
222340-287-33
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
15853c4f-032a-400d-bd42-80884314ec49
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 12, 2017
Package DI Number
30715418028591
Quantity per Package
2
Contains DI Package
20715418028594
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 |