Catalog Number

77001

Brand Name

Symmetry Olsen

Version/Model Number

77001

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

9d928b0b-a4c9-4d07-b55d-4646c5903644

Public Version Date

October 25, 2021

Public Version Number

5

DI Record Publish Date

September 13, 2016

Package DI Number

30841785109127

Quantity per Package

50

Contains DI Package

00841785109126

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-