Catalog Number

DECC056240

Brand Name

EliA SmDP Well

Version/Model Number

DECC056240

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

K132631,K132631

Product Code

LKP

Product Code Name

ANTI-SM ANTIBODY, ANTIGEN AND CONTROL

Public Device Record Key

7b79b2e7-e7dc-43a1-95ae-29d1dc861999

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

07333066010885

Quantity per Package

2

Contains DI Package

07333066014838

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-