Catalog Number

NL1805-12RFD

Brand Name

V. Mueller

Version/Model Number

NL1805-12RFD

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"

Yes

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

K831236,K831236

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

5d1041a3-e736-491b-bd0f-5540a42918be

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

November 27, 2017

Package DI Number

20885403460170

Quantity per Package

10

Contains DI Package

10885403460173

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box