Catalog Number

7-51552

Brand Name

SpecuLume

Version/Model Number

7-51552

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

HIC

Product Code Name

Speculum, Vaginal, Nonmetal, Fiberoptic

Public Device Record Key

f0f1906a-0cef-4628-a0e8-95667480d2f2

Public Version Date

November 23, 2021

Public Version Number

1

DI Record Publish Date

November 15, 2021

Package DI Number

10816908010839

Quantity per Package

25

Contains DI Package

00816908010832

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack