Atrauman Silicone st 10x20cm P10 C8 - Atrauman Silicone st 10x20cm P10 C8 - PAUL HARTMANN AG

Duns Number:315768788

Device Description: Atrauman Silicone st 10x20cm P10 C8

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More Product Details

Catalog Number

-

Brand Name

Atrauman Silicone st 10x20cm P10 C8

Version/Model Number

4995640

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)

-

Over the Counter (OTC)

Yes

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

fa559e40-c335-45fe-80a1-458830e95273

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

September 01, 2020

Additional Identifiers

Package DI Number

04052199254388

Quantity per Package

10

Contains DI Package

04052199255460

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PAUL HARTMANN AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 99
U Unclassified 1