Catalog Number

2B5LT

Brand Name

ENDOPATH XCEL OPTIVIEW

Version/Model Number

2B5LT

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

K032676,K032676,K032676

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

ccab37e9-05ba-417a-8a2b-3e75928e46d5

Public Version Date

January 09, 2020

Public Version Number

5

DI Record Publish Date

July 15, 2016

Package DI Number

30705036013703

Quantity per Package

24

Contains DI Package

10705036013709

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE