Catalog Number

1217-16

Brand Name

Medovations®

Version/Model Number

1217-16

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

ff7d8ea3-7d25-4151-b399-9370ba293e80

Public Version Date

April 10, 2019

Public Version Number

6

DI Record Publish Date

September 17, 2016

Package DI Number

M7831217161

Quantity per Package

50

Contains DI Package

M7831217160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case