Duns Number:002397347
Device Description: Surecan™ Safety II Port Access Needle set with Caresite® Y injection site 22G x 0.5in. (1 Surecan™ Safety II Port Access Needle set with Caresite® Y injection site 22G x 0.5in. (12mm)
Catalog Number
4447059-02
Brand Name
SURECAN SAFETY II
Version/Model Number
4447059-02
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
2e6386f7-d244-46f4-97a1-df677258c076
Public Version Date
March 03, 2020
Public Version Number
3
DI Record Publish Date
December 07, 2018
Package DI Number
04046955068951
Quantity per Package
5
Contains DI Package
04046964858956
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 |