Catalog Number

-

Brand Name

WECK VISTA

Version/Model Number

470403

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

-

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

8bb3eac7-6387-4717-87d5-da0be0dc497f

Public Version Date

June 08, 2021

Public Version Number

5

DI Record Publish Date

December 16, 2016

Package DI Number

30886874112688

Quantity per Package

5

Contains DI Package

10886874112684

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE