Duns Number:038000253
Device Description: 4F VESSEL DILATOR4F VESSEL DILAT (15CM / 0.025")(15CM / 0.025")
Catalog Number
MCD74
Brand Name
MEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR
Version/Model Number
MCD74
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"
Yes
For Single-Use
Yes
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
-
Product Code
DRE
Product Code Name
DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Public Device Record Key
26f0962f-0ff8-4f6c-b9dd-c19f77a433ae
Public Version Date
November 06, 2018
Public Version Number
1
DI Record Publish Date
October 06, 2018
Package DI Number
50884908127268
Quantity per Package
10
Contains DI Package
00884908127263
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 2560 |