NeoShade Small (Low-Profile) Hook - Phototherapy Eye Shield (Qty. 50) - Neotech Products LLC

Duns Number:198013435

Device Description: Phototherapy Eye Shield (Qty. 50)

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More Product Details

Catalog Number

N725

Brand Name

NeoShade Small (Low-Profile) Hook

Version/Model Number

10812594010955

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

Yes

Prescription Use (Rx)

Yes

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

FOK

Product Code Name

Pad, Neonatal Eye

Device Record Status

Public Device Record Key

18c1da91-6c53-45ea-b689-086f0ee674eb

Public Version Date

July 26, 2022

Public Version Number

3

DI Record Publish Date

May 18, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEOTECH PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 153
2 A medical device with a moderate to high risk that requires special controls. 27