Duns Number:038000253
Device Description: 0.038" (0.98MM) X 120CM0.038" (0 STRAIGHT FLEX GUIDEWIRESTRAIGHT WITH SHEATHWITH SHEATH
Catalog Number
DMC120
Brand Name
N/AN/A
Version/Model Number
DMC120
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
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
31130798-ae07-409c-963e-706e57032ec9
Public Version Date
September 13, 2019
Public Version Number
1
DI Record Publish Date
September 05, 2019
Package DI Number
30884908145152
Quantity per Package
10
Contains DI Package
00884908145151
Package Discontinue Date
-
Package Status
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 |