Catalog Number

-

Brand Name

Smart Plus

Version/Model Number

PHT-35LHS

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

K162660

Product Code

OAS

Product Code Name

X-Ray, Tomography, Computed, Dental

Public Device Record Key

925c9831-e759-4e2d-9cb5-b06b4dfb4e98

Public Version Date

June 29, 2021

Public Version Number

1

DI Record Publish Date

June 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-