DRYPRO SD-S - MEDICAL IMAGING FILM - KONICA MINOLTA, INC.

Duns Number:692076161

Device Description: MEDICAL IMAGING FILM

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More Product Details

Catalog Number

-

Brand Name

DRYPRO SD-S

Version/Model Number

A76J

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

IWZ

Product Code Name

Film, Radiographic

Device Record Status

Public Device Record Key

11a83277-92da-4476-b2f7-050117c5d385

Public Version Date

September 29, 2022

Public Version Number

1

DI Record Publish Date

September 21, 2022

Additional Identifiers

Package DI Number

64560141939280

Quantity per Package

4

Contains DI Package

44560141939286

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"KONICA MINOLTA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 130