TELAMax 1S - TELAMax 1S is a sterile bioscaffold composed of - TELA BIO, INC.

Duns Number:078721472

Device Description: TELAMax 1S is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix TELAMax 1S is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. The device consists of two sides: a textured and smooth side. The textured side of the device, indicated with blue polypropylene, provides a surface conducive for tissue ingrowth. The smooth side of the device, containing clear polypropylene, provides a surface designed to minimize tissue attachment. TELAMax 1S will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax 1S is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

F10069-1822

Brand Name

TELAMax 1S

Version/Model Number

F10069-1822

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 10, 2016

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

-

Product Code Details

Product Code

FTM

Product Code Name

Mesh, Surgical

Device Record Status

Public Device Record Key

66a7082e-7d49-47af-b7aa-bb69fa8584c3

Public Version Date

June 10, 2022

Public Version Number

5

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

-

"TELA BIO, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 15