Catalog Number

5185

Brand Name

ADC

Version/Model Number

5185

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

dc423eb6-6b6e-4a91-96bf-163c04944b7c

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

July 13, 2018

Package DI Number

00634782554255

Quantity per Package

10

Contains DI Package

00634782054465

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER