Duns Number:078684808
Device Description: Single use coring needle for retrieval of tissue samples. It is placed through a flexible Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope.
Catalog Number
10005-1
Brand Name
FleXNeedle
Version/Model Number
10005-1
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
K090853
Product Code
EOQ
Product Code Name
Bronchoscope (Flexible Or Rigid)
Public Device Record Key
2e8c1d55-d348-4ba5-9b08-51378eb3cd87
Public Version Date
February 22, 2019
Public Version Number
4
DI Record Publish Date
May 12, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |