Catalog Number

77005

Brand Name

Symmetry Olsen

Version/Model Number

77005

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

-

Product Code

HAM

Product Code Name

Apparatus, Electrosurgical

Public Device Record Key

24b0dda8-9099-4d3e-aa26-a2a19a6ae2ed

Public Version Date

October 25, 2021

Public Version Number

5

DI Record Publish Date

September 07, 2016

Package DI Number

30841785109134

Quantity per Package

50

Contains DI Package

00841785109133

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-