Duns Number:690543319
Device Description: R2P SlenGuide Guiding Catheter
Catalog Number
WG-S7ST1L23A
Brand Name
R2P SLENGUIDE
Version/Model Number
WG-S7ST1L23A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
-
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
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
e12d50a2-cecc-43ff-baff-63ade65a3c1f
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
September 29, 2017
Package DI Number
54987892046631
Quantity per Package
5
Contains DI Package
04987892046636
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 364 |
| 3 | A medical device with high risk that requires premarket approval | 29 |