Catalog Number

0408831000

Brand Name

Flyte, SurgiCool

Version/Model Number

0408831000

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

-

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

db691d76-7706-4630-8ec3-6a708411f378

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

37613327117128

Quantity per Package

9

Contains DI Package

07613327117127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack