Catalog Number

-

Brand Name

Speculum Neo-Natal Strong Spring Angled Temporal

Version/Model Number

31-3101

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HNC

Product Code Name

Specula, Ophthalmic

Public Device Record Key

011aad67-4d6b-4636-a231-e9d142467a99

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Package DI Number

05060480402164

Quantity per Package

10

Contains DI Package

05060480407664

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-