Catalog Number

-

Brand Name

DRYPRO SD-Q2

Version/Model Number

AE65

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

Yes

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

IWZ

Product Code Name

Film, Radiographic

Public Device Record Key

d4255d85-f80a-474c-a01d-6d151f2d5438

Public Version Date

September 28, 2022

Public Version Number

1

DI Record Publish Date

September 20, 2022

Package DI Number

14560141950617

Quantity per Package

4

Contains DI Package

04560141950610

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box