Duns Number:711789789
Device Description: MAJ-2316 DVI CABLE 3M
Catalog Number
-
Brand Name
DVI CABLE 3M
Version/Model Number
MAJ-2316
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
K190449,K193026
Product Code
FET
Product Code Name
Endoscopic video imaging system/component, gastroenterology-urology
Public Device Record Key
00ba1a92-3a6d-4b8f-8523-f17b8dc59574
Public Version Date
September 05, 2022
Public Version Number
3
DI Record Publish Date
May 27, 2020
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 | 117 |
2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
U | Unclassified | 52 |