Catalog Number

LEM-204-450

Brand Name

DANmed

Version/Model Number

LEM-204-450

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 08, 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"

Yes

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

K052759

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

007edc44-42c0-4365-b7e7-eca9dbfd8ecb

Public Version Date

September 09, 2022

Public Version Number

7

DI Record Publish Date

February 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-