Catalog Number

6985

Brand Name

PKIT, SST BI-LAT CHEST HIP COVERS

Version/Model Number

6985-1

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KME

Product Code Name

Bedding, Disposable, Medical

Public Device Record Key

49d1a004-c487-4f65-b6f8-9beb6bbfa0ab

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

September 03, 2020

Package DI Number

10842430112383

Quantity per Package

6

Contains DI Package

00842430112386

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case