Catalog Number

-

Brand Name

Mini Shears

Version/Model Number

171305

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2022

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

K951589,K951589

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

4f571409-a898-4293-9b94-8c9f2207175b

Public Version Date

September 14, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10884521066274

Quantity per Package

6

Contains DI Package

20884521066271

Package Discontinue Date

March 11, 2022

Package Status

Not in Commercial Distribution

Package Type

CASE