Duns Number:002348191
Device Description: SmartNeedle
Catalog Number
78040
Brand Name
SMARTNEEDLE
Version/Model Number
IPN039092
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
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
40d1c9dc-f157-487b-8bbf-e8c98d4f05d6
Public Version Date
February 14, 2020
Public Version Number
1
DI Record Publish Date
February 06, 2020
Package DI Number
20841156103450
Quantity per Package
10
Contains DI Package
10841156103453
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |