Catalog Number

-

Brand Name

Mini Step

Version/Model Number

MS101005

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

K961430,K961430

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

dc857562-65b8-4144-b610-e601b44068f3

Public Version Date

July 22, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10884521082731

Quantity per Package

10

Contains DI Package

20884521082738

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE