Catalog Number

AB2070

Brand Name

Balloon Applicator

Version/Model Number

720846

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090914

Product Code

JAD

Product Code Name

System, Therapeutic, X-Ray

Public Device Record Key

fe8a7ad8-82ed-4eb3-9413-7e51b9b4f263

Public Version Date

November 13, 2019

Public Version Number

1

DI Record Publish Date

November 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-