MedSource Sheet - Ready Fit Fitted sheet 90gsm - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: Ready Fit Fitted sheet 90gsm

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More Product Details

Catalog Number

Not Applicable

Brand Name

MedSource Sheet

Version/Model Number

MS-42210

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

3769a322-569e-4fcc-9b5a-375e6ff003e1

Public Version Date

July 15, 2021

Public Version Number

1

DI Record Publish Date

July 07, 2021

Additional Identifiers

Package DI Number

00840155401174

Quantity per Package

10

Contains DI Package

00840155401167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90