Duns Number:790265227
Device Description: Cannula Insertion System, 23 Gauge Sterile, Single Step, w/ Tubing Set
Catalog Number
5700SST
Brand Name
NA
Version/Model Number
5700SST
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 02, 2019
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
b3e82f77-077e-40f8-aa84-5b3d944d2f6f
Public Version Date
October 29, 2021
Public Version Number
5
DI Record Publish Date
June 24, 2017
Package DI Number
10812480010595
Quantity per Package
6
Contains DI Package
00812480010598
Package Discontinue Date
October 02, 2019
Package Status
Not 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 |