Catalog Number

RT-B889KYCF2A

Brand Name

Encompass™ SRS Fibreplast™ Anterior Mask

Version/Model Number

10841962110928

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K152321

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

2c6088c4-e315-407a-b875-1942ebe10ff1

Public Version Date

January 10, 2019

Public Version Number

1

DI Record Publish Date

December 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-