Silicone mat for sterilisation container for Mesher - Silicone mat for sterilisation container for - Nouvag AG

Duns Number:480610476

Device Description: Silicone mat for sterilisation container for Mesher

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More Product Details

Catalog Number

-

Brand Name

Silicone mat for sterilisation container for Mesher

Version/Model Number

4126

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"

-

For Single-Use

-

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

FZW

Product Code Name

Expander, Surgical, Skin Graft

Device Record Status

Public Device Record Key

644e45f9-7ec9-440d-b58c-86d9ea97cf36

Public Version Date

July 08, 2021

Public Version Number

3

DI Record Publish Date

August 21, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOUVAG AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 72
2 A medical device with a moderate to high risk that requires special controls. 95