Green Sprouts - First Teethers made from Silicone (3pk)-Aqua - I PLAY. INC.

Duns Number:131904450

Device Description: First Teethers made from Silicone (3pk)-Aqua Set-3mo+

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More Product Details

Catalog Number

-

Brand Name

Green Sprouts

Version/Model Number

385372-600-33

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 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

MEF

Product Code Name

Ring, Teething, Non-Fluid Filled

Device Record Status

Public Device Record Key

d45a8a33-8ad2-481c-92f3-a2db64c4e929

Public Version Date

June 09, 2021

Public Version Number

1

DI Record Publish Date

June 01, 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