Catalog Number

-

Brand Name

SafeOp

Version/Model Number

100602

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

K191723

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Public Device Record Key

dd4fa648-0979-464a-9096-7d98641342aa

Public Version Date

December 09, 2019

Public Version Number

1

DI Record Publish Date

December 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-