Catalog Number

-

Brand Name

Panther OIS R&V

Version/Model Number

v2.31

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

May 01, 2025

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100801,K122616

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

ef701fb4-fe93-4685-a42e-f43792559a15

Public Version Date

November 09, 2021

Public Version Number

1

DI Record Publish Date

November 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-