SurgiMend® - SurgiMend is an acellular dermal tissue matrix - TEI BIOSCIENCES INC.

Duns Number:796253292

Device Description: SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes, shapes, and thicknesses to be trimmed by the physician to meet the individual patient's needs.

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More Product Details

Catalog Number

606-403-001

Brand Name

SurgiMend®

Version/Model Number

606-403-001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K083898

Product Code Details

Product Code

FTM

Product Code Name

Mesh, surgical

Device Record Status

Public Device Record Key

458176f2-889d-4556-8b96-7d4e0383cd86

Public Version Date

August 26, 2022

Public Version Number

7

DI Record Publish Date

October 14, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEI BIOSCIENCES INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 81
U Unclassified 55