MedStream - DRESSING CHANGE KIT - MEDICAL SPECIALTIES DISTRIBUTORS, LLC

Duns Number:153608369

Device Description: DRESSING CHANGE KIT

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More Product Details

Catalog Number

MSDC-C22383

Brand Name

MedStream

Version/Model Number

MSDC-C22383

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

bcd2b0ca-3364-4ae3-99b7-40c893d504ad

Public Version Date

October 06, 2020

Public Version Number

3

DI Record Publish Date

February 13, 2019

Additional Identifiers

Package DI Number

10842472106913

Quantity per Package

30

Contains DI Package

00842472106916

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDICAL SPECIALTIES DISTRIBUTORS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 202
2 A medical device with a moderate to high risk that requires special controls. 86