Catalog Number

-

Brand Name

Scorpion

Version/Model Number

N/A

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K121931,K091410,K091410,K121931,K121931,K091410

Product Code

ETN

Product Code Name

Stimulator, Nerve

Public Device Record Key

8ef825ce-ef22-4aad-b716-a2c28a0eafea

Public Version Date

November 25, 2021

Public Version Number

1

DI Record Publish Date

November 17, 2021

Package DI Number

IDKATF714B5

Quantity per Package

5

Contains DI Package

B006IDKATF714B52

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-