4DDOME ® - The device 4DDOME® consists of a dome and - COUSIN BIOTECH

Duns Number:776742439

Device Description: The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anter The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.

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More Product Details

Catalog Number

-

Brand Name

4DDOME ®

Version/Model Number

4DDOM30GSR

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"

-

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

K070918

Product Code Details

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Device Record Status

Public Device Record Key

8130fe14-b4b1-42b4-a62c-adf06c77f914

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

October 23, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COUSIN BIOTECH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11