Catalog Number

1369

Brand Name

Busse Hospital Disposables

Version/Model Number

1369

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

FMJ

Product Code Name

Manometer, Spinal-Fluid

Public Device Record Key

1c1d76f2-3224-479d-91b9-3e78b440bb96

Public Version Date

September 18, 2020

Public Version Number

1

DI Record Publish Date

September 10, 2020

Package DI Number

10849233004914

Quantity per Package

10

Contains DI Package

00849233004917

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-