Catalog Number

986

Brand Name

Busse Hospital Disposables

Version/Model Number

986

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 15, 2022

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

K092338,K092338

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

9fdd5cf8-4f86-47e7-91d0-2bda6ad96372

Public Version Date

July 18, 2022

Public Version Number

4

DI Record Publish Date

September 02, 2016

Package DI Number

10849233013817

Quantity per Package

10

Contains DI Package

00849233013810

Package Discontinue Date

July 15, 2022

Package Status

Not in Commercial Distribution

Package Type

-