Catalog Number

384

Brand Name

Busse Hospital Disposables

Version/Model Number

384

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

K010835,K010835,K010835

Product Code

HFW

Product Code Name

Clamp, Umbilical

Public Device Record Key

c6dc3d35-acc8-4922-b1c5-9273a2b56434

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

20849233013036

Quantity per Package

64

Contains DI Package

10849233013039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-