Cytoflex Textured 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

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More Product Details

Catalog Number

C04-0101

Brand Name

Cytoflex Textured Tef-Guard

Version/Model Number

TEX-100

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

f3430b1f-83d4-4971-b1c8-c6667dc7d64e

Public Version Date

July 27, 2021

Public Version Number

4

DI Record Publish Date

November 23, 2016

Additional Identifiers

Package DI Number

D767C0401051

Quantity per Package

5

Contains DI Package

D767C0401010

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