Duns Number:140727624
Device Description: Seldinger Needle 19ga x 7cm
Catalog Number
SN1902
Brand Name
Seldinger Needle
Version/Model Number
SN1902
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
K974745,K974745
Product Code
DRC
Product Code Name
Trocar
Public Device Record Key
0f3efcc4-c9e7-4498-8a4d-f40aac3a77ee
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
September 16, 2016
Package DI Number
20886333003321
Quantity per Package
25
Contains DI Package
00886333003327
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 347 |
2 | A medical device with a moderate to high risk that requires special controls. | 1205 |