ComPel XTR OR Gown - OR GWN COMPEL XTR KAUM L/XL BL - RM (98 8130) - STANDARD TEXTILE CO., INC.

Duns Number:006999858

Device Description: OR GWN COMPEL XTR KAUM L/XL BL - RM (98 8130) USE: 75667265

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More Product Details

Catalog Number

7566N015

Brand Name

ComPel XTR OR Gown

Version/Model Number

7566N015

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

K922753,K922753

Product Code Details

Product Code

FYA

Product Code Name

Gown, Surgical

Device Record Status

Public Device Record Key

0ea9cd66-a3d1-4f01-8d93-c88f7c91b4f4

Public Version Date

April 07, 2021

Public Version Number

5

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