LANEX Fine Screens - PR 14X17 LANEX FINE SCR C2 W/O FOAM - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: PR 14X17 LANEX FINE SCR C2 W/O FOAM

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More Product Details

Catalog Number

1810910

Brand Name

LANEX Fine Screens

Version/Model Number

LANEX Fine Screens

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

EAM

Product Code Name

Screen, intensifying, radiographic

Device Record Status

Public Device Record Key

2b1cfbd1-3565-43e0-900e-4c2e585c480e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARESTREAM HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 688