Catalog Number

-

Brand Name

7-AMINO PLUS 100 NG/ML

Version/Model Number

7-AMINO+ 100 MP

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LAS

Product Code Name

Drug Specific Control Materials

Public Device Record Key

fc2b20f3-2e70-43ad-916c-5bf78aa0788a

Public Version Date

August 19, 2022

Public Version Number

1

DI Record Publish Date

August 11, 2022

Package DI Number

B80000357500031

Quantity per Package

4

Contains DI Package

B80000357500030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box