Catalog Number

P10105-150

Brand Name

iBEAM

Version/Model Number

P10105-150

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 12, 2021

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

-

Product Code

IXQ

Product Code Name

Table, Radiographic, Stationary Top

Public Device Record Key

5cbbb935-ad3a-482d-9c04-8a3b6a53fdc8

Public Version Date

October 13, 2021

Public Version Number

3

DI Record Publish Date

August 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-