Duns Number:711789789
Device Description: Single Use Aspiration Needle NA-U401SX-4025N
Catalog Number
-
Brand Name
OLYMPUS
Version/Model Number
NA-U401SX-4025N
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 21, 2022
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
K190239,K190239
Product Code
KTI
Product Code Name
Bronchoscope accessory
Public Device Record Key
7446e26b-2cde-415e-b5fa-d4e36bb0acc9
Public Version Date
February 22, 2022
Public Version Number
2
DI Record Publish Date
February 10, 2020
Package DI Number
14953170402019
Quantity per Package
1
Contains DI Package
04953170402012
Package Discontinue Date
February 21, 2022
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 | 117 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
| U | Unclassified | 52 |