Duns Number:142007082
Device Description: 5mm disposable aspiration needle, 21ga needle, 40cm length
Catalog Number
780-412
Brand Name
SurgyNeedle
Version/Model Number
780-412
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
GAA
Product Code Name
Needle, Aspiration And Injection, Disposable
Public Device Record Key
dc2f8931-2c37-47f0-ac51-8de1637ec04c
Public Version Date
July 12, 2019
Public Version Number
2
DI Record Publish Date
March 28, 2019
Package DI Number
00810014635132
Quantity per Package
100
Contains DI Package
00810014635125
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |