Duns Number:631805488
Catalog Number
-
Brand Name
Cyst Puncture Needle with Stylet
Version/Model Number
17812
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 27, 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
-
Product Code
KNA
Product Code Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Public Device Record Key
18683843-c6d0-42ea-a2c3-078fc4f8d389
Public Version Date
February 09, 2021
Public Version Number
3
DI Record Publish Date
January 09, 2018
Package DI Number
17350025915637
Quantity per Package
10
Contains DI Package
07350025915630
Package Discontinue Date
February 27, 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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 157 |