Duns Number:793169512
Device Description: 35X35CM MX CASS W/GRN 400 SCREEN
Catalog Number
6807069
Brand Name
Medical X-ray Cassette with Green 400 Screens
Version/Model Number
Medical X-ray Cassette with Green 400 Screens
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K896708,K896708
Product Code
IXA
Product Code Name
Cassette, radiographic film
Public Device Record Key
2d71984d-f5f7-40c6-add5-1513fa68f1be
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
60889976807064
Quantity per Package
5
Contains DI Package
40889976807060
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |