Minimax TRX-S - FILM TRX-S ADULT SIZE 2 PAPER FILM Intraoral Film - FLOW X RAY CORPORATION

Duns Number:010016319

Device Description: FILM TRX-S ADULT SIZE 2 PAPER FILM Intraoral Film (150)

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More Product Details

Catalog Number

-

Brand Name

Minimax TRX-S

Version/Model Number

20707

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

IWZ

Product Code Name

Film, Radiographic

Device Record Status

Public Device Record Key

37d9b3b5-deba-47d7-aaf7-a5e4703af730

Public Version Date

July 16, 2020

Public Version Number

1

DI Record Publish Date

July 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLOW X RAY CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3215