UNDERPAD QUILTED - UNDERPAD QUILTED KAUM BLUE/GRN 33X36 RM (98 8385) - STANDARD TEXTILE CO., INC.

Duns Number:006999858

Device Description: UNDERPAD QUILTED KAUM BLUE/GRN 33X36 RM (98 8385) USE: 59740200

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More Product Details

Catalog Number

597X6900

Brand Name

UNDERPAD QUILTED

Version/Model Number

597X6900

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

-

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

-

Product Code Details

Product Code

FMW

Product Code Name

Cover, Mattress (Medical Purposes)

Device Record Status

Public Device Record Key

2bf3be7b-b3f9-4cca-8da3-4d8af3ff2e1a

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

January 29, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STANDARD TEXTILE CO., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 9