Catalog Number

P10105-114

Brand Name

iBEAM

Version/Model Number

P10105-114

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 08, 2020

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

bfafad4f-5cea-4d00-80f4-831214df346a

Public Version Date

December 09, 2020

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

-