Duns Number:135057938
Device Description: Chiba Fine Needle Aspiration 21G X 15CM
Catalog Number
CHI2115
Brand Name
NA
Version/Model Number
CHI2115
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
-
Product Code
GAA
Product Code Name
NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
Public Device Record Key
f7a14147-a80b-48e4-849d-2266e3c797b5
Public Version Date
February 18, 2021
Public Version Number
4
DI Record Publish Date
July 18, 2018
Package DI Number
50885403088900
Quantity per Package
10
Contains DI Package
10885403088902
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2835 |
| 3 | A medical device with high risk that requires premarket approval | 190 |