Catalog Number

-

Brand Name

Balloon Extractor

Version/Model Number

BEX

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

-

Product Code

KBE

Product Code Name

Snare, Nasal

Public Device Record Key

b642437c-0f92-4d37-87d0-78c1cf3f6ecf

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Package DI Number

10855364004099

Quantity per Package

10

Contains DI Package

00855364004092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box