Catalog Number

-

Brand Name

BUSULFAN LEVEL 3

Version/Model Number

BUS 3 P F UK

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

9d2531bf-e88c-4db1-9d12-ef6b951cceea

Public Version Date

August 25, 2022

Public Version Number

1

DI Record Publish Date

August 17, 2022

Package DI Number

B80001696000091

Quantity per Package

4

Contains DI Package

B80001696000090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box