Duns Number:005910997
Device Description: Doll Teether~The Doll Teether is a multi-textured toy and provides your child with differe Doll Teether~The Doll Teether is a multi-textured toy and provides your child with different surfaces to feel and touch. It also will give your child warmth and security.
Catalog Number
-
Brand Name
Baby King/Cribmates
Version/Model Number
BK77424/CM77424DG
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
KYX
Product Code Name
Dispenser, Liquid Medication
Public Device Record Key
bbe987d7-39bb-4a40-b5d2-ce8165531b68
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 08, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |