Green Sprouts - Cool Fruit Teether-Assorted-3mo+ - I PLAY. INC.

Duns Number:131904450

Device Description: Cool Fruit Teether-Assorted-3mo+

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More Product Details

Catalog Number

-

Brand Name

Green Sprouts

Version/Model Number

222340-920-33

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2021

Issuing Agency

In GS1

Product Characteristics

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"

Yes

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 Details

Product Code

KKO

Product Code Name

Ring, Teething, Fluid-Filled

Device Record Status

Public Device Record Key

e57d2a6f-388e-49b2-9566-f389895a79b6

Public Version Date

June 08, 2021

Public Version Number

1

DI Record Publish Date

May 31, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"I PLAY. INC." Characteristics
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