Catalog Number

EL-FTS01

Brand Name

Ellacor

Version/Model Number

EL-FTS01

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"

-

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

K202517

Product Code

QAI

Product Code Name

Powered Microneedle Device

Public Device Record Key

773a5f1b-f1da-4a6c-8826-d824e60adb0a

Public Version Date

October 08, 2021

Public Version Number

1

DI Record Publish Date

September 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-