Green Sprouts - Cool Nature Teether - Yellow/Aqua Set - I PLAY. INC.

Duns Number:131904450

Device Description: Cool Nature Teether - Yellow/Aqua Set

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More Product Details

Catalog Number

-

Brand Name

Green Sprouts

Version/Model Number

385345-400-33

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2020

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"

-

For Single-Use

Yes

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

e3297231-25f0-44c5-acce-762ef8f5b2a7

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

September 23, 2020

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