Catalog Number

0301

Brand Name

MeDiCa

Version/Model Number

0301

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

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

K790295

Product Code

DBM

Product Code Name

Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Public Device Record Key

f03386c6-d485-415b-8425-edadd41c8c25

Public Version Date

December 09, 2020

Public Version Number

1

DI Record Publish Date

December 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-