Catalog Number

9120000

Brand Name

Sun Medical Inc

Version/Model Number

SFE200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K911154

Product Code

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Public Device Record Key

a0105826-885e-418c-8a3b-5facd971372e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-