Catalog Number

5236LS

Brand Name

BOEHRINGER® ViSiGi 3D™ Low Suction Sleeve Gastrectomy Calibration Sys, size 36Fr

Version/Model Number

5236LS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2017

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

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

6bdf2f8a-df24-4232-8f1a-2dca48804ec0

Public Version Date

March 26, 2020

Public Version Number

4

DI Record Publish Date

May 01, 2017

Package DI Number

30816286020738

Quantity per Package

5

Contains DI Package

10816286020734

Package Discontinue Date

December 31, 2017

Package Status

Not in Commercial Distribution

Package Type

BOX