Catalog Number

-

Brand Name

Large applicator

Version/Model Number

899-AP-C-1

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"

-

For Single-Use

-

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

fb97ee4b-2ea3-4d7c-a261-7568b89e6620

Public Version Date

March 10, 2020

Public Version Number

1

DI Record Publish Date

March 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-