Duns Number:790265227
Device Description: Cannula Insertion System, 27 Gauge, Sterile, Single Step GEN II, w/ Tubing Set
Catalog Number
5500GST
Brand Name
NA
Version/Model Number
5500GST
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
-
Product Code
HMX
Product Code Name
Cannula, Ophthalmic
Public Device Record Key
2f5237b7-6bd9-4c20-a60f-97173d6532cf
Public Version Date
October 29, 2021
Public Version Number
4
DI Record Publish Date
June 24, 2017
Package DI Number
10812480010694
Quantity per Package
6
Contains DI Package
00812480010697
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |