Duns Number:018652637
Device Description: XCOIL Retractor - 12mm x 125cm (Short Eyelet)
Catalog Number
-
Brand Name
XCOIL Retractor
Version/Model Number
XR100-2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2020
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
DXE
Product Code Name
Catheter, Embolectomy
Public Device Record Key
67db1b6b-7374-42dd-afb6-a8a2b96f9ded
Public Version Date
October 24, 2022
Public Version Number
8
DI Record Publish Date
May 31, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |