Catalog Number

98701

Brand Name

AVANOS

Version/Model Number

98701

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K093312

Product Code

KGC

Product Code Name

TUBE, GASTRO-ENTEROSTOMY

Public Device Record Key

9256de07-17de-41d1-a4ba-34459fc4daac

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

May 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-