Catalog Number

-

Brand Name

Covidien

Version/Model Number

UNVCA12STS

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

K172097,K172097

Product Code

NLM

Product Code Name

Laparoscope, General & Plastic Surgery, Reprocessed

Public Device Record Key

d98a683d-ccd8-4b8b-87f7-97a6a162704b

Public Version Date

March 01, 2021

Public Version Number

3

DI Record Publish Date

January 15, 2019

Package DI Number

B504UNVCA12STS1

Quantity per Package

6

Contains DI Package

B504UNVCA12STS0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box