Catalog Number

10189

Brand Name

Fentanyl Analogues 2ng/mL

Version/Model Number

10189

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

9684b5dc-4bfe-4a19-a79d-d623b81ed5e1

Public Version Date

April 23, 2020

Public Version Number

1

DI Record Publish Date

April 15, 2020

Package DI Number

B800101895

Quantity per Package

5

Contains DI Package

B800101890

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box