Duns Number:017283879
Device Description: The MiniFESS Sickle Knife is a reusable device used to cut tissue in the nasal or sinus ca The MiniFESS Sickle Knife is a reusable device used to cut tissue in the nasal or sinus cavity.
Catalog Number
-
Brand Name
MiniFESS Sickle Knife
Version/Model Number
CS-105
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
-
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
KTG
Product Code Name
Knife, Ent
Public Device Record Key
e3b867bf-bdf3-460a-828c-49e2114ca7d5
Public Version Date
September 16, 2020
Public Version Number
1
DI Record Publish Date
September 08, 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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |