Roentgen Files - Roentgen Files 4.1.0 - Brit Systems, LLC

Duns Number:941442410

Device Description: Roentgen Files 4.1.0

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More Product Details

Catalog Number

-

Brand Name

Roentgen Files

Version/Model Number

4.1.0

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

LMB

Product Code Name

Device, Digital Image Storage, Radiological

Device Record Status

Public Device Record Key

42d7e8f2-8a9f-4a5b-928e-1b786b7e1d27

Public Version Date

June 11, 2021

Public Version Number

2

DI Record Publish Date

September 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BRIT SYSTEMS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 44
2 A medical device with a moderate to high risk that requires special controls. 8