Duns Number:151507563
Device Description: NEEDLES, W/O BASEPLATE 3.8CM 18g
Catalog Number
-
Brand Name
Procedure Products Needles
Version/Model Number
31-1815
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K810859
Product Code
DRE
Product Code Name
Dilator, Vessel, For Percutaneous Catheterization
Public Device Record Key
06668bd9-984a-4459-88e5-7a367551c8cd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 07, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 98 |