Duns Number:071595540
Device Description: WANG PLEURAL TAPPING NEEDLE KIT
Catalog Number
Kit-1780
Brand Name
WANG
Version/Model Number
Kit-1780
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 08, 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"
-
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
K894326,K894326,K894326
Product Code
GAA
Product Code Name
NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
Public Device Record Key
f2becba9-99a2-42bf-83d6-b0d1c2b27493
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
10653405058250
Quantity per Package
5
Contains DI Package
20653405058257
Package Discontinue Date
June 08, 2022
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |