Catalog Number

-

Brand Name

Panther OIS

Version/Model Number

v3.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 16, 2027

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

-

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

K211760

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

0c229143-4286-4d44-9d4c-c5a7c2ab2158

Public Version Date

March 24, 2022

Public Version Number

1

DI Record Publish Date

March 16, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-