Duns Number:006133784
Device Description: SureCUT Suture Cutter
Catalog Number
FG-0006-02
Brand Name
SureCUT
Version/Model Number
50-01
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
FZT
Product Code Name
Cutter, Surgical
Public Device Record Key
4cb217f3-78a2-4fb4-9f53-ffd8cfc0e19b
Public Version Date
August 06, 2021
Public Version Number
1
DI Record Publish Date
July 29, 2021
Package DI Number
30840143903674
Quantity per Package
1
Contains DI Package
10840143904400
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |
| 3 | A medical device with high risk that requires premarket approval | 11 |