UNDERPAD QUILTED IBEX - UNDERPAD QUILTED CANADIAN IBEX KAUM 33X36 RM (98 - STANDARD TEXTILE CO., INC.

Duns Number:006999858

Device Description: UNDERPAD QUILTED CANADIAN IBEX KAUM 33X36 RM (98 6656) USE: 59750110

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

597E8410

Brand Name

UNDERPAD QUILTED IBEX

Version/Model Number

597E8410

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

534b6d99-fdc9-4aaa-aea8-fd486ed11309

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