Catalog Number

-

Brand Name

Greentek

Version/Model Number

Flex-Cap BM-FA01-23ST

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K200162,K200162

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

32629b2b-4a33-40cf-b42b-83703ba45228

Public Version Date

July 28, 2021

Public Version Number

1

DI Record Publish Date

July 20, 2021

Package DI Number

06970295340065

Quantity per Package

10

Contains DI Package

06970295340003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-