Catalog Number

-

Brand Name

ORCA Foam

Version/Model Number

Size 50HD

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

Product Code

KHJ

Product Code Name

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

Public Device Record Key

63584bd8-3a7b-4336-abe2-ea546642c0ac

Public Version Date

March 04, 2022

Public Version Number

1

DI Record Publish Date

February 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-