Duns Number:038000253
Device Description: 0.035" (0.89MM) X 70CM0.035" (0. MARKED J-TIP GUIDEWIREMARKED J-T
Catalog Number
DMC35-JM
Brand Name
CARDIOVSCULAR SPRING GUIDESCARDIOVSCULAR SPRING GUIDES
Version/Model Number
DMC35-JM
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
ea89d586-396d-417a-a7f6-fb9feefe1d61
Public Version Date
July 03, 2019
Public Version Number
1
DI Record Publish Date
June 25, 2019
Package DI Number
30884908141994
Quantity per Package
10
Contains DI Package
00884908141993
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 |