Catalog Number

-

Brand Name

Valleylab

Version/Model Number

SEP5000

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

K182772,K182772,K182772

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

4d0f3922-d7c8-4b87-adb9-a0c5fcce0323

Public Version Date

February 09, 2022

Public Version Number

2

DI Record Publish Date

January 11, 2019

Package DI Number

20884521750590

Quantity per Package

5

Contains DI Package

10884521750593

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK