Duns Number:361663839
Device Description: NEEDLES 23x1
Catalog Number
-
Brand Name
NEEDLES 23x1
Version/Model Number
11-231
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193526,K193526
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
f84e24a5-0e1f-40e4-87fa-f1647985fd7b
Public Version Date
January 11, 2021
Public Version Number
1
DI Record Publish Date
January 01, 2021
Package DI Number
00369771001822
Quantity per Package
100
Contains DI Package
00369771001815
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 23 |