Catalog Number

122120

Brand Name

Impact™

Version/Model Number

122120

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 04, 2021

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"

Yes

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

K931009

Product Code

KNQ

Product Code Name

Dilator, esophageal

Public Device Record Key

2901c70c-0a9e-4d99-a017-76cd73eca05a

Public Version Date

August 06, 2021

Public Version Number

6

DI Record Publish Date

August 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-