Radiographic Film Cassette - Improving Image Quality Reducing Patient - JPI HEALTHCARE. CO., LTD.

Duns Number:687797852

Device Description: Improving Image Quality Reducing Patient Exposure, Being Easy-to-handle.

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More Product Details

Catalog Number

-

Brand Name

Radiographic Film Cassette

Version/Model Number

AFAB TYPE

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)

-

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

IXA

Product Code Name

Cassette, Radiographic Film

Device Record Status

Public Device Record Key

03f41b8c-14c8-43d9-8297-36b741e7e7b6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JPI HEALTHCARE. CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 11