Tixel - Tixel Back Unit - NOVOXEL LTD

Duns Number:600275858

Device Description: Tixel Back Unit

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More Product Details

Catalog Number

TXLD0002

Brand Name

Tixel

Version/Model Number

TXLD0002

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"

-

For Single-Use

-

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

K202988

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

2da5b82a-1901-43c5-8ac2-bd9694b01573

Public Version Date

November 01, 2021

Public Version Number

1

DI Record Publish Date

October 24, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVOXEL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6