Catalog Number

-

Brand Name

SafeOp

Version/Model Number

100720

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

K182542

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

58a40e95-a72d-4009-b218-b881c2594aaa

Public Version Date

January 08, 2020

Public Version Number

1

DI Record Publish Date

December 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-