Duns Number:038000253
Device Description: 8F (1.0MM ID, 2.7MM OD)8F (1.0MM VESSEL DILATORVESSEL DILATOR (15CM/0.038")(15CM/0.038")
Catalog Number
MC78
Brand Name
MEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR
Version/Model Number
MC78
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2019
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
682fa32d-34f2-4d3c-96f3-34ec7c3f8d3f
Public Version Date
August 02, 2019
Public Version Number
2
DI Record Publish Date
October 24, 2018
Package DI Number
50884908029890
Quantity per Package
10
Contains DI Package
00884908029895
Package Discontinue Date
July 31, 2019
Package Status
Not 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 |