Catalog Number

-

Brand Name

Symmetry Olsen

Version/Model Number

97500

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

K862367,K862367

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

d0647537-97d2-423c-af35-2bc9b740ca62

Public Version Date

October 21, 2020

Public Version Number

4

DI Record Publish Date

January 12, 2017

Package DI Number

30841785111410

Quantity per Package

50

Contains DI Package

00841785111419

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-