Duns Number:038000253
Device Description: 4F REG MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE WITH RADIOPAQUE TIP
Catalog Number
RMS19421
Brand Name
Micro-Stick Set®
Version/Model Number
RMS19421
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
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
c1cb37fe-e369-4111-ae4b-3774b45419d9
Public Version Date
December 02, 2020
Public Version Number
2
DI Record Publish Date
November 05, 2020
Package DI Number
30884908158190
Quantity per Package
10
Contains DI Package
00884908158199
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 |