Duns Number:544042626
Device Description: This product is composed of cathode,anode and glass shell.The product is suitable for medi This product is composed of cathode,anode and glass shell.The product is suitable for medical diagnostic X-ray machine.
Catalog Number
-
Brand Name
Mingwei
Version/Model Number
MWTX77-0.7/1.3-135
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
-
Product Code
ITY
Product Code Name
Assembly, Tube Housing, X-Ray, Diagnostic
Public Device Record Key
fd1312c4-3d60-475e-a9bf-30f731bea4af
Public Version Date
May 17, 2021
Public Version Number
1
DI Record Publish Date
May 07, 2021
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 42 |