Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

2288L1

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

49c9738d-6a69-452c-997c-1c94d7084ebe

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

December 27, 2019

Package DI Number

D8382288L18

Quantity per Package

20

Contains DI Package

D8382288L12

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE