Catalog Number

692

Brand Name

Busse Hospital Disposables

Version/Model Number

692

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

K843496,K843496

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

11480d63-5a0e-4ad3-83a3-a68c858c36d2

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

September 02, 2016

Package DI Number

10849233013466

Quantity per Package

50

Contains DI Package

00849233013469

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-