Centurion - DRESSING CHANGE TRAY - CENTURION MEDICAL PRODUCTS CORPORATION

Duns Number:017246562

Device Description: DRESSING CHANGE TRAY

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More Product Details

Catalog Number

DT22815

Brand Name

Centurion

Version/Model Number

DT22815

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

LRP

Product Code Name

TRAY, SURGICAL

Device Record Status

Public Device Record Key

0ef76bb8-b742-42e8-a989-399adeb659c3

Public Version Date

July 26, 2022

Public Version Number

1

DI Record Publish Date

July 18, 2022

Additional Identifiers

Package DI Number

00653160354041

Quantity per Package

40

Contains DI Package

10653160354048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CENTURION MEDICAL PRODUCTS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6043
2 A medical device with a moderate to high risk that requires special controls. 4077
U Unclassified 1