Duns Number:529853921
Device Description: The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of th
Catalog Number
-
Brand Name
Shoocin
Version/Model Number
RS040518S-II
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"
Yes
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
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
0065add9-6ff1-4bb8-a343-4a69c369a4e3
Public Version Date
June 07, 2019
Public Version Number
2
DI Record Publish Date
May 13, 2019
Package DI Number
16936733740771
Quantity per Package
5
Contains DI Package
06936733740774
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 89 |