Duns Number:131489882
Device Description: R2P Destination Slender Guiding Sheath
Catalog Number
GS-R6ST1C10W
Brand Name
R2P Destination Slender
Version/Model Number
GS-R6ST1C10W
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"
-
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
27d5ee50-c917-4ac3-ba62-7b6232cc7640
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
April 10, 2020
Package DI Number
50389701012358
Quantity per Package
5
Contains DI Package
00389701012353
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 142 |
3 | A medical device with high risk that requires premarket approval | 4 |