Duns Number:806136177
Device Description: 6F10cm HW Radial
Catalog Number
506610H
Brand Name
RAIN Sheath Transradial
Version/Model Number
506610H
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
98fcc80e-7b50-4728-b42b-fc068b3624f6
Public Version Date
September 14, 2022
Public Version Number
7
DI Record Publish Date
October 09, 2018
Package DI Number
20705032079034
Quantity per Package
5
Contains DI Package
10705032079037
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2567 |
3 | A medical device with high risk that requires premarket approval | 204 |