Catalog Number

DBL-505

Brand Name

UtahBall

Version/Model Number

Ball Electrode

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K905263,K951032,K905263,K951032

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

84a2ae93-9679-4b58-a1ae-d76e669f80ff

Public Version Date

December 18, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

H671DBL5051

Quantity per Package

10

Contains DI Package

H671DBL5050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box