Duns Number:001292192
Device Description: NEEDLE ADMIX NOKOR 18X1-1/2 TW
Catalog Number
305215
Brand Name
BD Nokor
Version/Model Number
305215
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
30116773-f1d5-4e4b-8877-6592a0ad1b43
Public Version Date
July 09, 2020
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
50382903052153
Quantity per Package
1000
Contains DI Package
00382903052158
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 | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |