Cytoflex Smooth Tef-Guard - Cytoflex® Tef-Guard® is a non-resorbable membrane - UNICARE BIOMEDICAL INC.

Duns Number:038023573

Device Description: Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in gui Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex® Tef-Guard® has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex® Tef-Guard® is for use as a barrier membrane for guided tissue regeneration procedures. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications.

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More Product Details

Catalog Number

C01-0301

Brand Name

Cytoflex Smooth Tef-Guard

Version/Model Number

TEF-001

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

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

K012144,K012144

Product Code Details

Product Code

NPK

Product Code Name

Barrier, Synthetic, Intraoral

Device Record Status

Public Device Record Key

e0f7b8cf-db5b-437f-8f5c-22d2d37d8ee5

Public Version Date

July 27, 2021

Public Version Number

4

DI Record Publish Date

November 23, 2016

Additional Identifiers

Package DI Number

D767C0103051

Quantity per Package

5

Contains DI Package

D767C0103010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"UNICARE BIOMEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11
U Unclassified 1