Duns Number:806136177
Device Description: RAILWAY ACCESS KIT, 5F, ADT, HW WIRE
Catalog Number
RW5ADTH
Brand Name
RAILWAY
Version/Model Number
RW5ADTH
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
9ccae7f1-5678-4688-947a-88f155d9d218
Public Version Date
September 14, 2022
Public Version Number
7
DI Record Publish Date
May 31, 2018
Package DI Number
20705032076835
Quantity per Package
5
Contains DI Package
10705032076838
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 |