Duns Number:627879687
Device Description: The Articulator injection needle is a single use, disposable, flexible sheath injection ne The Articulator injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes.
Catalog Number
00711804
Brand Name
Articulator
Version/Model Number
00711804
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"
Yes
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
FCG
Product Code Name
Biopsy needle
Public Device Record Key
ebdf3500-cd58-4b91-a1fa-2811983855db
Public Version Date
November 10, 2020
Public Version Number
2
DI Record Publish Date
April 01, 2020
Package DI Number
10724995180840
Quantity per Package
5
Contains DI Package
00724995180843
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |