Duns Number:005910997
Device Description: Doll Teether~The Doll Teether is a multi-textured toy and provides your child different su Doll Teether~The Doll Teether is a multi-textured toy and provides your child different surfaces to feel and touch. It also enhances your baby's sense of security and comfort. Distributed by MidwoodBrands LLC 10611 Monroe Road, Matthews, North Carolina 28105 USA. MidwoodBrands LLC 0322510458060617
Catalog Number
-
Brand Name
Kidgets Doll Teether
Version/Model Number
SKU 1600132
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"
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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
aa020f69-e4f4-47d0-b0b6-b9055fba167b
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 |