Duns Number:374444883
Device Description: USABS CAS US GREEN 400 24X30
Catalog Number
EHYJ6
Brand Name
Green RE 400 Speed
Version/Model Number
Green RE 400 Speed 24X30
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
3ce0d6d3-a274-4963-9034-157ed30430d0
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 |