Catalog Number

-

Brand Name

Nella NuSpec

Version/Model Number

NU001

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"

Yes

For Single-Use

-

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

HIB

Product Code Name

Speculum, Vaginal, Nonmetal

Public Device Record Key

d7eb014c-15e5-4ccc-9d5a-b90a06f39405

Public Version Date

August 28, 2020

Public Version Number

2

DI Record Publish Date

August 18, 2020

Package DI Number

10860000270424

Quantity per Package

10

Contains DI Package

00860000270427

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box of 10