Catalog Number

0277600100

Brand Name

iSwitch

Version/Model Number

0277600100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 07, 2018

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

-

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

K033135

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

0cc0a234-a7ce-40ca-a2bf-1a7b98d650fc

Public Version Date

September 16, 2022

Public Version Number

11

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-