DRESSING CHANGE TRAY - CONVENIENCE KIT FOR NEW OR REPLACEMENT DRESSING - STRADIS MEDICAL LLC

Duns Number:043537671

Device Description: CONVENIENCE KIT FOR NEW OR REPLACEMENT DRESSING

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More Product Details

Catalog Number

-

Brand Name

DRESSING CHANGE TRAY

Version/Model Number

MSDC-C18300

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

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

OXQ

Product Code Name

Dressing Change Tray

Device Record Status

Public Device Record Key

0b96811c-c9ca-41c2-ba3d-0e5d81c379bc

Public Version Date

May 24, 2022

Public Version Number

1

DI Record Publish Date

May 16, 2022

Additional Identifiers

Package DI Number

M752MSDCC183005

Quantity per Package

24

Contains DI Package

M752MSDCC183000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box

"STRADIS MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 38