Duns Number:544042626
Device Description: This product is composed of cathode, anode and glass shell.The product is suitable for med 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
MWTX71-0.6/1.2-125S
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"
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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
8682a5eb-9a14-4cce-a042-9b2cb0a516d3
Public Version Date
August 16, 2022
Public Version Number
1
DI Record Publish Date
August 08, 2022
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 |