Catalog Number

DECC056720

Brand Name

EliA SmDP-S Well

Version/Model Number

DECC056720

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

-

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

K202067,K202067

Product Code

LKP

Product Code Name

ANTI-SM ANTIBODY, ANTIGEN AND CONTROL

Public Device Record Key

37931db5-1ddd-4e74-8ac1-b78985cab7aa

Public Version Date

July 28, 2021

Public Version Number

1

DI Record Publish Date

July 20, 2021

Package DI Number

07333066017709

Quantity per Package

4

Contains DI Package

07333066021485

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-