Kidgets - Sunglasses (non-prescription) Regulation Number - Family Dollar Stores

Duns Number:117310689

Device Description: Sunglasses (non-prescription) Regulation Number 886.5850 Device Class 1

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More Product Details

Catalog Number

-

Brand Name

Kidgets

Version/Model Number

SKU#1699231

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

HQY

Product Code Name

Sunglasses (Non-Prescription Including Photosensitive)

Device Record Status

Public Device Record Key

ad6f097d-7eb9-4646-a518-23a5fb2240f1

Public Version Date

August 09, 2021

Public Version Number

3

DI Record Publish Date

May 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FAMILY DOLLAR STORES" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 5