Duns Number:038000253
Device Description: 0.038" (0.97MM) X 70CM0.038" (0. J/FLEX MARKED GUIDEWIREJ/FLEX MA
Catalog Number
RMS19603
Brand Name
CARDIOVASCULAR SPRING GUIDESCARDIOVASCULAR SPRING GUIDES
Version/Model Number
RMS19603
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 25, 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
9978f851-83ba-4ccd-bee7-255b2c440020
Public Version Date
June 23, 2021
Public Version Number
2
DI Record Publish Date
October 06, 2018
Package DI Number
30884908038331
Quantity per Package
10
Contains DI Package
00884908038330
Package Discontinue Date
March 25, 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 |