Catalog Number

14-0310

Brand Name

ESI GloSpec

Version/Model Number

140310

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

HIB

Product Code Name

Speculum, Vaginal, Nonmetal

Public Device Record Key

669b06b7-05d8-406a-a29a-5404b7941e35

Public Version Date

January 06, 2020

Public Version Number

1

DI Record Publish Date

December 27, 2019

Package DI Number

B3961403102

Quantity per Package

100

Contains DI Package

B3961403100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case