Duns Number:134614411
Device Description: Sterile needle guide (12-18ga) with (14 x 147cm) telescopically-folded CIV-Flex™ cover wit Sterile needle guide (12-18ga) with (14 x 147cm) telescopically-folded CIV-Flex™ cover with Envision™
Catalog Number
610-2346
Brand Name
Infiniti Plus Needle Guide
Version/Model Number
610-2346
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
K093713,K093713
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
a4ced0e4-50b1-4d19-bb32-1e6ed591e4a5
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
January 22, 2021
Package DI Number
00841436120142
Quantity per Package
24
Contains DI Package
10841436120149
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 |