Catalog Number

5211-6

Brand Name

ADC®

Version/Model Number

5211-6

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EPY

Product Code Name

Speculum, Ent

Public Device Record Key

73ebccce-e320-464b-a390-0bd6ffa97514

Public Version Date

September 13, 2019

Public Version Number

1

DI Record Publish Date

September 05, 2019

Package DI Number

00634782840211

Quantity per Package

10

Contains DI Package

00634782040383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack