Duns Number:006133784
Device Description: FindrWIRZ Guide Wire System
Catalog Number
FG-005
Brand Name
FindrWIRZ
Version/Model Number
40-05
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
K080364,K080364,K080364,K080364
Product Code
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
f416b5ce-222e-4f26-acc3-91605f87a1f2
Public Version Date
January 19, 2021
Public Version Number
1
DI Record Publish Date
January 11, 2021
Package DI Number
30840143901762
Quantity per Package
1
Contains DI Package
10840143901751
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |
| 3 | A medical device with high risk that requires premarket approval | 11 |