Catalog Number

0408-210-000

Brand Name

Flyte

Version/Model Number

0408210000

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

LYU

Product Code Name

ACCESSORY, SURGICAL APPAREL

Public Device Record Key

ed45c794-f9ec-44ca-8c97-f6771448155b

Public Version Date

April 15, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2018

Package DI Number

34546540591563

Quantity per Package

8

Contains DI Package

04546540591562

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack