Catalog Number

1115.A

Brand Name

Diathermy cable for forceps 1115 & 1116

Version/Model Number

1115.A

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

-

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

K190875

Product Code

HQR

Product Code Name

Apparatus, Cautery, Radiofrequency, Ac-Powered

Public Device Record Key

03510291-f889-4451-ace9-3be4995bedf7

Public Version Date

March 17, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-