Catalog Number

43507

Brand Name

TAUT

Version/Model Number

IPN006942

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

bfabfd8b-e764-4ab2-bbff-e13fa1169ba0

Public Version Date

January 09, 2020

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

44027604418868

Quantity per Package

4

Contains DI Package

24026704418866

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box