Catalog Number

2350

Brand Name

Busse Hospital Disposables

Version/Model Number

2350

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

Product Code

FYC

Product Code Name

Gown, Isolation, Surgical

Public Device Record Key

84f70320-2140-4417-800a-8a122c9de5fd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 02, 2016

Package DI Number

10849233016665

Quantity per Package

10

Contains DI Package

00849233016668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-