Duns Number:001292192
Device Description: NEEDLE 18X1 RB
Catalog Number
305195
Brand Name
N/A
Version/Model Number
305195
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
K021475,K021475,K021475
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
f1e599a3-0ad9-43f0-b45f-4d4706cd9aa7
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
50382903051958
Quantity per Package
10
Contains DI Package
30382903051954
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 |