TRACOE® care - TRACOE purofoam Tracheostomy Dressing large - Tracoe medical GmbH

Duns Number:319414785

Device Description: TRACOE purofoam Tracheostomy Dressing large

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More Product Details

Catalog Number

-

Brand Name

TRACOE® care

Version/Model Number

REF 958

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

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NAD

Product Code Name

Dressing,wound,occlusive

Device Record Status

Public Device Record Key

7d695ea5-a827-4d8c-992e-494a2158047c

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

March 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRACOE MEDICAL GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 88
2 A medical device with a moderate to high risk that requires special controls. 1963