CURIX ORTHO MEDIUM - CURIX CAS US+OR MED 35X43 - AGFA

Duns Number:374444883

Device Description: CURIX CAS US+OR MED 35X43

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More Product Details

Catalog Number

3KTRP

Brand Name

CURIX ORTHO MEDIUM

Version/Model Number

CURIX ORTHO MEDIUM 35X43

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K023020

Product Code Details

Product Code

IXA

Product Code Name

Cassette, radiographic film

Device Record Status

Public Device Record Key

476ab7f4-28b2-428e-a31a-a5ad2a2b3b54

Public Version Date

June 14, 2019

Public Version Number

4

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AGFA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 202