Duns Number:711789789
Device Description: "MAJ-968 UPD MONITOR CABLE B 525CM"
Catalog Number
-
Brand Name
LCD monitor cable B
Version/Model Number
MAJ-968
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 09, 2022
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
K002749
Product Code
FDF
Product Code Name
Colonoscope and accessories, flexible/rigid
Public Device Record Key
76362ee7-4795-48f9-bf58-9a0a79bff48b
Public Version Date
August 10, 2022
Public Version Number
4
DI Record Publish Date
September 21, 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 |
---|---|---|
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 |