Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

FS2288P

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

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

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

b59d4e36-4337-4c49-890b-02b30b22d309

Public Version Date

October 19, 2020

Public Version Number

1

DI Record Publish Date

October 10, 2020

Package DI Number

D838FS2288P8

Quantity per Package

20

Contains DI Package

D838FS2288P2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case