Catalog Number

-

Brand Name

Moore Medical

Version/Model Number

68721

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

K020726,K020726,K020726

Product Code

HIB

Product Code Name

Speculum, Vaginal, Nonmetal

Public Device Record Key

396d960e-49a3-4460-aae5-3aa67572b757

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 09, 2016

Package DI Number

40607415001806

Quantity per Package

10

Contains DI Package

20607415001796

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case