Catalog Number

1027563

Brand Name

Safco X-Pose intraoral x-ray film

Version/Model Number

1027563

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IWZ

Product Code Name

Film, radiographic

Public Device Record Key

eefd10fe-62fc-417a-8dec-21f8bc0860f6

Public Version Date

September 16, 2020

Public Version Number

1

DI Record Publish Date

September 08, 2020

Package DI Number

D72310275633

Quantity per Package

3

Contains DI Package

D7231027563

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box