Catalog Number

5158

Brand Name

Busse Hospital Disposables

Version/Model Number

5158

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

2900bc31-351a-4772-8135-c33004fb9eab

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 13, 2016

Package DI Number

10849233000978

Quantity per Package

10

Contains DI Package

00849233000971

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-