Duns Number:065183758
Device Description: LAMAZE JD Chill Teether
Catalog Number
L27412
Brand Name
LAMAZE/JOHN DEERE
Version/Model Number
L27412
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KKO
Product Code Name
Ring, Teething, Fluid-Filled
Public Device Record Key
46d1a14b-7203-4d10-b879-2747a802515f
Public Version Date
October 01, 2019
Public Version Number
1
DI Record Publish Date
September 23, 2019
Package DI Number
B268L274122
Quantity per Package
2
Contains DI Package
B268L274120
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail Package
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |