Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

S901XL-IY

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

EJB

Product Code Name

Handle, Instrument, Dental

Public Device Record Key

b21821dc-237c-4bf1-b777-9529c418bbf5

Public Version Date

January 17, 2020

Public Version Number

1

DI Record Publish Date

January 09, 2020

Package DI Number

D838S901XLIY8

Quantity per Package

2

Contains DI Package

D838S901XLIY6

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE