Duns Number:134614411
Device Description: Sterile needle guide with (17.8 x 147cm) telescopically-folded CIV-Flex™ cover for use wit Sterile needle guide with (17.8 x 147cm) telescopically-folded CIV-Flex™ cover for use with Canon Medical Systems PVI-450BPX (i8CXP1) transducers
Catalog Number
680-172, 680-172-5
Brand Name
Integrated Needle Guide
Version/Model Number
680-172, 680-172-5
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"
Yes
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
IYO
Product Code Name
System, imaging, pulsed echo, ultrasonic
Public Device Record Key
be0fd04c-06bd-4d56-bab8-98245c57ac3b
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
November 20, 2021
Package DI Number
00841436118705
Quantity per Package
12
Contains DI Package
10841436118702
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 |