Conexa Reconstructive Tissue Matrix - Conexa 5cm x 10cm Thick Pliable Product, Rotator - LIFECELL CORPORATION

Duns Number:157224205

Device Description: Conexa 5cm x 10cm Thick Pliable Product, Rotator Cuff

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More Product Details

Catalog Number

0510003

Brand Name

Conexa Reconstructive Tissue Matrix

Version/Model Number

0510003

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2018

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

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

FTL

Product Code Name

Mesh, Surgical, Polymeric

Device Record Status

Public Device Record Key

c6fc6c4a-4112-41ab-a6fc-8f9093e78041

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 17, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFECELL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8