Premium Flat Cot Sheet - Premium Flat Cot Sheet, Dark Blue, 40" x 72" - DYNAREX CORPORATION

Duns Number:008124539

Device Description: Premium Flat Cot Sheet, Dark Blue, 40" x 72" (101.6cm x 183cm)

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More Product Details

Catalog Number

-

Brand Name

Premium Flat Cot Sheet

Version/Model Number

3508

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

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 Details

Product Code

KME

Product Code Name

Bedding, Disposable, Medical

Device Record Status

Public Device Record Key

0619336e-9c45-450a-8394-b12286c221f2

Public Version Date

May 03, 2022

Public Version Number

1

DI Record Publish Date

April 25, 2022

Additional Identifiers

Package DI Number

00616784350837

Quantity per Package

50

Contains DI Package

00616784350813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2