FILM DX-42 NO. 3 BITE-CHEX PAPER BITEWING D SPEED - FILM INTRAORAL X-RAY, FILM DX-42 NO. 3 BITE-CHEX - FLOW X RAY CORPORATION

Duns Number:010016319

Device Description: FILM INTRAORAL X-RAY, FILM DX-42 NO. 3 BITE-CHEX PAPER BITEWING D SPEED, 100pcs/box

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More Product Details

Catalog Number

-

Brand Name

FILM DX-42 NO. 3 BITE-CHEX PAPER BITEWING D SPEED

Version/Model Number

18060-E

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

7e37daab-9876-4d43-9147-ac1fc7f91e0f

Public Version Date

July 09, 2020

Public Version Number

1

DI Record Publish Date

July 01, 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