Catalog Number

-

Brand Name

Valleylab

Version/Model Number

E1654B

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

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

c2a05f97-6bb1-4116-ac0f-1542e7b60a59

Public Version Date

May 26, 2022

Public Version Number

3

DI Record Publish Date

November 18, 2016

Package DI Number

10884524002750

Quantity per Package

20

Contains DI Package

20884524002757

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE