Duns Number:109903521
Device Description: CANNU-FLEX 1.5 MM X 305 MM .062 INCH X 12 INCH GUIDE WI CANNU-FLEX 1.5 MM X 305 MM .062 INCH X 12 INCH GUIDE WIRE
Catalog Number
014859
Brand Name
BIORCI
Version/Model Number
014859
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
HWQ
Product Code Name
PASSER
Public Device Record Key
ed8f9bf3-e11e-4229-9667-b74b32bf68d6
Public Version Date
November 03, 2020
Public Version Number
4
DI Record Publish Date
August 30, 2015
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |