Duns Number:134614411
Device Description: Sterile navigator with (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex™ sensor Sterile navigator with (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex™ sensor cover for use with 10-14GA instruments
Catalog Number
610-1153
Brand Name
VirtuTRAX Instrument Navigator
Version/Model Number
610-1153
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
K092619,K092619
Product Code
IYO
Product Code Name
System, imaging, pulsed echo, ultrasonic
Public Device Record Key
4e5001fe-91bf-480c-a234-d2c6c66004cd
Public Version Date
September 06, 2021
Public Version Number
7
DI Record Publish Date
August 22, 2017
Package DI Number
00841436102285
Quantity per Package
5
Contains DI Package
10841436102282
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 443 |