Catalog Number

N6501

Brand Name

Ocular Exam Kit Neonatal

Version/Model Number

10812594011853

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

FXG

Product Code Name

Specula Accessories

Public Device Record Key

16c2c913-bab3-4277-86eb-5f9dffd4698c

Public Version Date

July 26, 2022

Public Version Number

2

DI Record Publish Date

June 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-