Duns Number:109903521
Device Description: CANNU-FLEX SCREW GUIDE WIRE, 1.5 MM X 12 INCH 30 CM 6 P CANNU-FLEX SCREW GUIDE WIRE, 1.5 MM X 12 INCH 30 CM 6 PER PACKAGE
Catalog Number
014545
Brand Name
CANNU-FLEX
Version/Model Number
014545
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
b4f4d0a6-b41a-4e6b-b684-fac39dc13087
Public Version Date
October 09, 2020
Public Version Number
4
DI Record Publish Date
August 30, 2015
Package DI Number
23596010096108
Quantity per Package
6
Contains DI Package
03596010096104
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
TB
| 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 |