Catalog Number

9040

Brand Name

Symmetry Surgical®

Version/Model Number

9040

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 9999

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

K113776

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

fb9417ee-9c88-47a4-80b8-87a63abfc0c9

Public Version Date

February 21, 2019

Public Version Number

2

DI Record Publish Date

September 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-