Duns Number:071595540
Device Description: Y-Knot OneStep Guide, Fishmouth, Disposable
Catalog Number
Y1SG1D
Brand Name
Y-KNOT ONESTEP
Version/Model Number
Y1SG1D
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 20, 2020
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
FZX
Product Code Name
Guide, surgical, instrument
Public Device Record Key
90703615-057e-45a5-8d8f-e8e459851a8d
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
June 24, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |