FILM FSS-58 D ADULT SINGLE BUTTERFLY PACKETS F SPEED - FILM FSS-58 D ADULT SINGLE BUTTERFLY PACKETS F - FLOW X RAY CORPORATION

Duns Number:010016319

Device Description: FILM FSS-58 D ADULT SINGLE BUTTERFLY PACKETS F SPEED, FILM INTRAORAL X-RAY

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More Product Details

Catalog Number

-

Brand Name

FILM FSS-58 D ADULT SINGLE BUTTERFLY PACKETS F SPEED

Version/Model Number

19620E

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

f75f9bbb-9982-40d7-a831-9a31dde296f1

Public Version Date

August 17, 2020

Public Version Number

1

DI Record Publish Date

August 07, 2020

Additional Identifiers

Package DI Number

10812045030495

Quantity per Package

25

Contains DI Package

00812045030498

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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