Catalog Number

109001T

Brand Name

NOVATECH® TALCAIR™

Version/Model Number

109001T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K151832,K151832

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

180c0d65-498c-44b4-917f-cabb2499734d

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

October 19, 2017

Package DI Number

EBES109001T1

Quantity per Package

2

Contains DI Package

EBES109001T0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton