Catalog Number

-

Brand Name

NeoDevices, Inc.

Version/Model Number

FTM8.0P-EL

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

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

dd6610b7-a192-4d13-94a4-298a4517b825

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10816340028232

Quantity per Package

10

Contains DI Package

10816340021400

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-