SOFSORB OR TOWEL - OR TOWEL SOFSORB KAUM ALPINE 17X32 RM (98 8199) - STANDARD TEXTILE CO., INC.

Duns Number:006999858

Device Description: OR TOWEL SOFSORB KAUM ALPINE 17X32 RM (98 8199) USE: 49100151

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More Product Details

Catalog Number

491W4051

Brand Name

SOFSORB OR TOWEL

Version/Model Number

491W4051

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

FRL

Product Code Name

Fiber, Medical, Absorbent

Device Record Status

Public Device Record Key

f10c509f-41e6-4c85-85c2-97d780fe75a0

Public Version Date

March 29, 2018

Public Version Number

2

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