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
00711810
Brand Name
Articulator
Version/Model Number
00711810
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 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"
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
5bf9f67c-01da-48e9-8fef-0e3ee7bd9557
Public Version Date
March 31, 2020
Public Version Number
5
DI Record Publish Date
September 17, 2016
Package DI Number
10816765011888
Quantity per Package
10
Contains DI Package
00816765011881
Package Discontinue Date
March 31, 2020
Package Status
Not 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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |