Catalog Number

-

Brand Name

BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 36Fr w/bulb

Version/Model Number

5236B

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"

Yes

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

K130483,K130483,K130483

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

b094fe66-8f46-43f4-9009-2833742e8485

Public Version Date

April 02, 2021

Public Version Number

5

DI Record Publish Date

August 01, 2016

Package DI Number

30816286020639

Quantity per Package

5

Contains DI Package

10816286020635

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box