Darby Dental Supply, LLC - X-RAY FILM F SPEED FS-01 #0 - DARBY DENTAL SUPPLY, LLC

Duns Number:825137818

Device Description: X-RAY FILM F SPEED FS-01 #0

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

9521144

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9521144

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

-

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

76cad463-66cf-4a9a-847e-f287290dbf04

Public Version Date

November 01, 2019

Public Version Number

1

DI Record Publish Date

October 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DARBY DENTAL SUPPLY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1457
2 A medical device with a moderate to high risk that requires special controls. 194
U Unclassified 2