Catalog Number

8101

Brand Name

Busse Hospital Disposables

Version/Model Number

8101

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

-

Product Code

OGJ

Product Code Name

Nerve Block Tray

Public Device Record Key

1fbfe38b-46d8-4621-9be7-46db1b1adda6

Public Version Date

March 26, 2020

Public Version Number

5

DI Record Publish Date

September 14, 2016

Package DI Number

10849233016283

Quantity per Package

10

Contains DI Package

00849233016286

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-