Catalog Number

9002782

Brand Name

CUSTOMED

Version/Model Number

712057712782

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"

-

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

K050887,K050887,K050887

Product Code

HIB

Product Code Name

Speculum, Vaginal, Nonmetal

Public Device Record Key

362d96d6-93cb-494a-8da9-b5f8aa5ec9a8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

M20890027822

Quantity per Package

10

Contains DI Package

M20890027823

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10/BAG, 10BAGS/CS