Catalog Number

-

Brand Name

Premium Flat Cot Sheet

Version/Model Number

3517

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

d8e9c1fa-1303-4451-b89a-ab1d50b7ba44

Public Version Date

September 09, 2021

Public Version Number

1

DI Record Publish Date

September 01, 2021

Package DI Number

00616784351735

Quantity per Package

50

Contains DI Package

00616784351711

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case