Catalog Number

AEG-1SC-060

Brand Name

Ameritus

Version/Model Number

AEG-1SC-060

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"

Yes

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

K100366,K100366,K100366

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

0c6573ee-16c5-4778-9e20-6104f15acb7b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 01, 2016

Package DI Number

30817551011589

Quantity per Package

500

Contains DI Package

10817522011585

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case