Catalog Number

-

Brand Name

ORCA Foam

Version/Model Number

Standard

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

K060878,K060878,K060878

Product Code

KHJ

Product Code Name

Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

Public Device Record Key

1c470ab0-aece-4e6c-80ae-562cabe0e902

Public Version Date

December 23, 2020

Public Version Number

1

DI Record Publish Date

December 15, 2020

Package DI Number

10860003109912

Quantity per Package

12

Contains DI Package

00860003109915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case