Duns Number:017283879
Device Description: The MiniFESS Blakesley Forceps is a reusable device used to grasp, manipulate or extract t The MiniFESS Blakesley Forceps is a reusable device used to grasp, manipulate or extract tissue in the nasal or sinus cavity.
Catalog Number
-
Brand Name
MiniFESS Blakesley Forceps Thru-Cut 45 Degree
Version/Model Number
CS-103
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
KAE
Product Code Name
Forceps, Ent
Public Device Record Key
8bf357ad-b754-40f7-b142-d6b2a80b0cc6
Public Version Date
December 22, 2021
Public Version Number
2
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 |