SILVER D: DV-53 - D SPEED SIZE 0 CHILD FILM, 100 DOUBLE FILMS PER - FLOW X RAY CORPORATION

Duns Number:010016319

Device Description: D SPEED SIZE 0 CHILD FILM, 100 DOUBLE FILMS PER BOX.

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More Product Details

Catalog Number

-

Brand Name

SILVER D: DV-53

Version/Model Number

18236

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

3b4be540-0bf0-46d0-8a7a-f395f092bff6

Public Version Date

January 06, 2020

Public Version Number

3

DI Record Publish Date

August 15, 2016

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