Duns Number:711789789
Device Description: Single Use Aspiration Needle NA-U201H
Catalog Number
-
Brand Name
Olympus
Version/Model Number
NA-U201H-8022
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
K181994,K181994
Product Code
FCG
Product Code Name
Biopsy needle
Public Device Record Key
e9af81af-7757-4068-9db6-263c30ae7845
Public Version Date
February 22, 2022
Public Version Number
3
DI Record Publish Date
November 06, 2018
Package DI Number
14953170402606
Quantity per Package
1
Contains DI Package
04953170402609
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 |