Duns Number:374444883
Device Description: CURIX CAS US+OR MED 35X43
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
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
IXA
Product Code Name
Cassette, radiographic film
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 202 |