Duns Number:787026855
Device Description: Cool gel that soothes gumsRidges to massage sore gumsEasy-to-grip ring shape
Catalog Number
-
Brand Name
Fun Ice Ring Teether- 2pk
Version/Model Number
43486
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
KKO
Product Code Name
Ring, Teething, Fluid-Filled
Public Device Record Key
ce121e9c-c154-42ed-aa55-f5edecb6a801
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 12, 2019
Package DI Number
10735282434867
Quantity per Package
24
Contains DI Package
00735282434860
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |