Catalog Number

235

Brand Name

Busse Hospital Disposables

Version/Model Number

235

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K941845,K941845,K941845

Product Code

FYC

Product Code Name

Gown, Isolation, Surgical

Public Device Record Key

f1f1a925-21d3-4690-908a-aa6fee5618f9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

10849233000572

Quantity per Package

15

Contains DI Package

00849233000575

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-