Duns Number:038000253
Device Description: 13F VESSEL DILATOR13F VESSEL DIL (15CM / 0.038")(15CM / 0.038")
Catalog Number
MCD73
Brand Name
MEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR
Version/Model Number
MCD73
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
2fd04be5-26b2-436a-a19e-2a7689cfe1f9
Public Version Date
November 06, 2018
Public Version Number
1
DI Record Publish Date
October 06, 2018
Package DI Number
50884908127350
Quantity per Package
10
Contains DI Package
00884908127355
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 |