Catalog Number

-

Brand Name

iBOT(R)

Version/Model Number

iBOT PMD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

IMK

Product Code Name

Wheelchair, Stair Climbing

Public Device Record Key

f77641ad-8d97-454a-9452-91d7a6b3b4ee

Public Version Date

June 14, 2022

Public Version Number

1

DI Record Publish Date

June 06, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-