Catalog Number

08056964

Brand Name

Soprano® 10

Version/Model Number

08056964

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192251

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

c8335031-9ead-4824-9ccf-3a5e700525ba

Public Version Date

February 20, 2020

Public Version Number

2

DI Record Publish Date

February 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-