Catalog Number

35150

Brand Name

TAUT

Version/Model Number

IPN006693

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2021

Issuing Agency

In GS1

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

K010007,K010007,K010007

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

c1039260-d69e-4dde-a69b-ea7ec744f700

Public Version Date

August 02, 2021

Public Version Number

8

DI Record Publish Date

September 16, 2016

Package DI Number

24026704418859

Quantity per Package

6

Contains DI Package

04026704418855

Package Discontinue Date

July 30, 2021

Package Status

Not in Commercial Distribution

Package Type

Box