Catalog Number

-

Brand Name

Valleylab

Version/Model Number

E2515HDB

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

K813071,K813071

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

2cd39aca-ec5c-45b4-bed1-92363d49c93a

Public Version Date

October 11, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884524000524

Quantity per Package

50

Contains DI Package

10884524000527

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE