Duns Number:134614411
Device Description: Sterile needle, 16GA x 6cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with Sterile needle, 16GA x 6cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVCO 16GA needle sensor
Catalog Number
610-1606-10
Brand Name
eTRAX™ Needle
Version/Model Number
610-1606-10
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 24, 2020
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
685e188f-e5d8-4fff-850d-6932042c7d8d
Public Version Date
September 03, 2021
Public Version Number
4
DI Record Publish Date
August 29, 2017
Package DI Number
00841436103336
Quantity per Package
10
Contains DI Package
10841436103333
Package Discontinue Date
July 24, 2020
Package Status
Not 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 |