Duns Number:106580145
Device Description: 4F Micro Introducer Kit, Nitinol Guidewire
Catalog Number
INT0400
Brand Name
Aligned Medical Solutions
Version/Model Number
INT0400
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
b9a472e2-f947-4573-a331-a10db639c52b
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
November 14, 2018
Package DI Number
B098INT04001
Quantity per Package
20
Contains DI Package
B098INT04000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 578 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1711 |