Duns Number:038000253
Device Description: 0.010" (0.27MM) X 60CM0.010" (0. STAINLESS STEEL GUIDEWIRESTAINLE W/HYDROPHILIC COATINGW/H 0.010" (0.27MM) X 60CM0.010" (0. STAINLESS STEEL GUIDEWIRESTAINLE W/HYDROPHILIC COATINGW/HYDROPHIL
Catalog Number
-
Brand Name
MEDCOMP .010" VASCULAR GUIDEWIREMEDCOMP .010" VASCULAR GUIDEWIRE
Version/Model Number
MR190060
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 29, 2021
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
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
ff1f0237-83ba-4f16-83d8-a22d6508be95
Public Version Date
February 03, 2021
Public Version Number
6
DI Record Publish Date
December 02, 2017
Package DI Number
30884908105262
Quantity per Package
10
Contains DI Package
00884908105261
Package Discontinue Date
January 29, 2021
Package Status
Not in Commercial Distribution
Package Type
inner 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 |