Duns Number:002397347
Device Description: Surecan™ Safety II Port Access Needle Set 19G x 0.8in. (20mm)
Catalog Number
4447001-02
Brand Name
SURECAN SAFETY II
Version/Model Number
4447001-02
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
PTI
Product Code Name
Non-Coring (Huber) Needle
Public Device Record Key
5bc82480-f4b1-4674-9137-408b32364706
Public Version Date
March 03, 2020
Public Version Number
8
DI Record Publish Date
December 22, 2017
Package DI Number
04046964999727
Quantity per Package
5
Contains DI Package
04046955156245
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 277 |
U | Unclassified | 2 |